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Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Merit Systems Protection Board.
Final rule.
This final rule adjusts the level of civil monetary penalties (CMPs) in regulations maintained and enforced by the Merit Systems Protection Board (MSPB) with an annual adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) and Office of Management and Budget (OMB) guidance.
This final rule is effective on January 21, 2022.
Jennifer Everling, Acting Clerk of the Board, Merit Systems Protection Board, 1615 M Street NW, Washington, DC 20419; phone: (202) 653-7200; Fax: (202) 653-7130; or email:
The Federal Civil Penalties Inflation Adjustment Act of 1990 (the 1990 Act), Public Law 101-410, provides for the regular evaluation of CMPs by Federal agencies. Periodic inflationary adjustments of CMPs ensure that the consequences of statutory violations adequately reflect the gravity of such offenses and that CMPs are properly accounted for and collected by the Federal Government. In April 1996, the 1990 Act was amended by the Debt Collection Improvement Act of 1996 (the 1996 Act), Public Law 104-134, requiring Federal agencies to adjust their CMPs at least once every four years. However, because inflationary adjustments to CMPs were statutorily capped at ten percent of the maximum penalty amount, but only required to be calculated every four years, CMPs in many cases did not correspond with the true measure of inflation over the preceding four-year period, leading to a decline in the real value of the penalty. To remedy this decline, the 2015 Act (section 701 of Pub. L. 114-74) requires agencies to adjust CMP amounts with annual inflationary adjustments through a rulemaking using a methodology mandated by the legislation. The purpose of these adjustments is to maintain the deterrent effect of civil penalties.
A civil monetary penalty is “any penalty, fine, or other sanction” that: (1) “is for a specific amount” or “has a maximum amount” under Federal law; and (2) a Federal agency assesses or enforces “pursuant to an administrative proceeding or a civil action in the Federal courts.” 28 U.S.C. 2461 note.
The MSPB is authorized to assess CMPs pursuant to 5 U.S.C. 1215(a)(3) and 5 U.S.C. 7326 in disciplinary actions brought by the Special Counsel. The corresponding MSPB regulation for both CMPs is 5 CFR 1201.126(a). As required by the 2015 Act, and pursuant to guidance issued by OMB, MSPB is now making an annual adjustment for 2022, according to the prescribed formulas.
The CMP listed in 5 U.S.C. 1215(a)(3) was established in 1978 with the enactment of the Civil Service Reform Act of 1978 (CSRA), Public Law 95-454, section 202(a), 92 Stat. 1121-30 (Oct. 13, 1978), and originally codified at 5 U.S.C. 1207(b). That CMP was last amended by section 106 of the Whistleblower Protection Enhancement Act of 2012, Public Law 112-199, 12 Stat. 1468 (Nov. 27, 2012), now codified at 5 U.S.C. 1215(a)(3), which provided for a CMP “not to exceed $1,000.” The CMP authorized in 5 U.S.C. 7326 was established in 2012 by section 4 of the Hatch Act Modernization Act of 2012 (Hatch Act), Public Law 112-230, 126 Stat. 1617 (Dec. 28, 2012), which provided for a CMP “not to exceed $1,000.” On February 2, 2021, MSPB issued a final rule which increased the maximum CMP allowed under both 5 U.S.C. 1215(a)(3) and 5 U.S.C. 7326 to $1,125 for the year 2021.
On December 15, 2021, OMB issued guidance on calculating the annual inflationary adjustment for 2022.
The revised CMP amounts will go into effect on January 21, 2022. All violations for which CMPs are assessed after the effective date of this rule will be assessed at the adjusted penalty level regardless of whether the violation occurred before the effective date.
Pursuant to 5 U.S.C. 553(b), the MSPB has determined that good cause exists for waiving the general notice of proposed rulemaking and public comment procedures as to these technical amendments. The notice and comment procedures are being waived because Congress has specifically exempted agencies from these requirements when implementing the 2015 Act. The 2015 Act explicitly requires the agency to make subsequent annual adjustments notwithstanding 5 U.S.C. 553, the section of the Administrative Procedure Act that normally requires agencies to engage in notice and comment. It is also in the public interest that the adjusted rates for CMPs under the CSRA and the Hatch Act become effective as soon as possible to maintain their effective deterrent effect.
The MSPB has determined that this is not a significant regulatory action under E.O. 12866. Therefore, no regulatory impact analysis is required.
The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule.
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. Chapter 35).
Pursuant to the Congressional Review Act (5 U.S.C. 801,
Administrative practice and procedure, Civil rights, Government employees.
For the reasons set forth above, 5 CFR part 1201 is amended as follows:
5 U.S.C. 1204, 1305, and 7701, and 38 U.S.C. 4331, unless otherwise noted.
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain type certificated Model UH-1H restricted category helicopters. This AD was prompted by multiple reports of failure of the main driveshaft. This AD requires establishing a limit to replace certain main driveshafts, and a one-time and repetitive inspections of the main driveshafts. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective February 25, 2022.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 25, 2022.
For service information identified in this final rule, contact U.S. Army Materiel Command Logistics Data Analysis Center (USAMC LDAC), ATTN: Equipment Publication Control Officers (EPCOs), Building 3305, Redeye Road, Redstone Arsenal, AL 35898-7466; telephone (256) 955-7716 or 1-866-211-3367; email
You may also contact the following as applicable:
Arrow Falcon Exporters Inc., 2081 S Wildcat Way, Porterville, CA 93257; telephone (559) 781-8604; fax (559) 781-9271; email
Global Helicopter Technology, Inc., P.O. Box 180681, Arlington, Texas 76096; telephone (817) 557-3391; email
Hagglund Helicopters, LLC, 5101 NW A Avenue, Pendleton, OR 97801; telephone (800) 882-3554 or (541) 276-3554; fax (541) 276-1597.
JASPP Engineering Services, LLC., 511 Harmon Terrace, Arlington, TX 76010; telephone (817) 465-4495; or at
Northwest Rotorcraft, LLC, 1000 85th Ave. SE, Olympia, WA 98501; telephone (360) 754-7200; or at
Overseas Aircraft Support, Inc., P.O. Box 898, Lakeside, AZ 85929; telephone (928) 368-6965; fax (928) 368-6962.
Richards Heavylift Helo, Inc., 1181 Osprey Nest Point, Orange Park, FL 32073; (904) 472-1481; email
Rotorcraft Development Corporation, P.O. Box 430, Corvallis, MT 59828; telephone (207) 329-2518; email
Southwest Florida Aviation International, Inc., 28000-A9 Airport Road, Bldg. 101, Punta Gorda, FL 33982-9587; telephone (941) 637-1161; fax (941) 637-6264; email
Tamarack Helicopters, Inc., 2849 McIntyre Rd., Stevensville, MT 59870; telephone (406) 777-0144; or at
You may view the service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110. Service information that is incorporated by reference is also available at
You may examine the AD docket at
Ameet Shrotriya, Aerospace Engineer, Delegation Oversight Section, DSCO Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5525; email
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to restricted category Model UH-1H helicopters with KAflex main driveshaft part number (P/N) SKCP2180-1, SKCP2281-1,
The FAA received comments from seven commenters. The commenters were Kamatics Corporation; Northwest Helicopters, LLC; Salmon River Helicopters; and four individuals. The following presents the comments received on the NPRM and the FAA's response to each comment.
Salmon River Helicopters and two individual commenters requested information about the driveshaft failures and one individual commenter asked if the issue is unsafe.
The FAA utilized the FAA's Service Difficulty Reporting System (SDRS) database,
An individual commenter asked for information about main driveshaft P/Ns SKCP2180-1 and SKCP2281-1R.
Main driveshaft P/Ns SKCP2180-1 and SKCP2281-1R are older P/Ns that currently have approval for installation in the domestic fleet and could be in service. Those two P/Ns are included in this AD due to design similarity and the determination that they are affected by the unsafe condition in this AD.
An individual commenter stated that National Stock Number (NSN) 615-01-072-5670 is used for both main driveshaft P/N CP2281-103, which is affected by this AD, and main driveshaft P/N SKCP3303-1, which is not affected by this AD. The commenter asked how main driveshaft P/N CP2281-103 is affected by this AD and not main driveshaft P/N SKCP3303-1 when, according to the NSN, they are built to the same standard.
An NSN is an identification label assigned to an item or a group of similar items, not limited to aircraft parts, and is used for procurement purposes in the Department of Defense (DOD) inventory. An NSN provides a common nomenclature of function, not a standard, and is used in a catalog system that is cross-compatible within multiple agencies under DOD. A P/N is assigned by the manufacturer. The applicability of this AD is narrowed down to any P/Ns that have an unsafe condition. Main driveshaft P/N SKCP3303-1 is an alternative part, and the FAA does not have information indicating that it is affected by the unsafe condition in this AD.
Northwest Helicopters, LLC, and an individual commenter asked if the 5,000 total hours TIS removal is a retirement life limit or an overhaul life limit. The individual commenter requested that if it is an overhaul life limit, the AD state that KAflex main driveshaft P/N SKCP2281-103 can be overhauled in accordance with the US Army, Depot Maintenance Work Requirement (DMWR) 55-1615-278.
The FAA partially agrees. The FAA agrees that a main driveshaft could be overhauled. Accordingly, the requirements proposed in paragraphs (g)(1) and (2) of the NPRM to remove the main driveshaft from service have been changed to replace the main driveshaft in this final rule. Additionally, clarification that the main driveshaft may be overhauled has been added to each instance to replace the main driveshaft in the Required Actions paragraph. The overhaul must be accomplished by following FAA-approved procedures. U.S. Army Aviation and Missile Command, DMWR for Main Drive Shaft DMWR 55-1615-278, Original Issuance, dated September 30, 2009 (DMWR 55-1615-278), specifies procedures that are not FAA-approved. The FAA disagrees with requiring DMWR 55-1615-278 to accomplish an overhaul as it requires specialized tooling to which owners/operators may not have access. Operators may, however, under the provisions of paragraph (h) of this AD, request approval of an alternative method of compliance (AMOC) to use DMWR 55-1615-278.
Kamatics Corporation stated that an older main driveshaft can be rebuilt or upgraded into main driveshaft P/N SKCP3303-1 at a lower cost than installing a new main driveshaft and requested the FAA add this alternative cost information.
The FAA agrees that some main driveshafts could be overhauled into main driveshaft P/N SKCP3303-1 and has updated the Costs of Compliance section accordingly.
Kamatics Corporation stated that service hours for most of the fielded main driveshafts is often not known and an individual commenter asked what to do if the proof of time since new on the main drive shaft is not recorded in any aircraft logs.
The FAA recognizes that this situation could exist. In light of this, the FAA has determined to require using the helicopter's total hours TIS if the total hours TIS of the main driveshaft cannot be determined.
Kamatics Corporation requested the AD require that any main driveshaft teardown be accomplished by an FAA-approved facility. Kamatics Corporation stated that inspection for wear within critical bolt joints requires a teardown. Kamatics Corporation stated that UH-1H Technical Manual paragraph 6-24.5 of Change 13 states “do not attempt to loosen or tighten any hardware (with respect to the drive shaft).”
The FAA disagrees. While the owner/operator may choose to have the actions
An individual commenter requested the FAA revise the AD so actions that are required by following certain procedures in TM 55-1520-210-23-1 Change 42, would be required using Headquarters, Department of the Army, Aviation Unit and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-1H/X Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 47, dated September 20, 2005 (TM 55-1520-210-23-1 Change 47), instead because TM 55-1520-210-23-1 Change 47 is the current change.
The FAA agrees to allow TM 55-1520-210-23-1 Change 47 as an option.
An individual commenter requested the FAA revise the AD to reference U.S. Army DMWR 55-1615-278 because this service information provides inspection and repair criteria for (main) driveshaft P/N SKCP2281-103 once it has been removed from the helicopter.
The FAA agrees. The FAA has reviewed this service information and added it to the Other Related Service Information section.
Kamatics Corporation requested the FAA revise the AD to require removal of main driveshaft P/Ns SKCP2180-1, SKCP 2281-1, and SKCP2281-1R from service. According to Kamatics Corporation, those P/Ns were removed from service by the U.S. Army due to flex frame bolted joint deterioration.
The FAA disagrees because no data has been provided to substantiate the commenter's request.
The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, including updating the contact information for the U.S. Army, clarifying the specific portions of TM 55-1520-210-23-1 Change 42 that are required to accomplish this Final rule, and the changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.
The FAA reviewed “Figure 4-9. Engine Air Inlet Filter Installation” on page 4-16; page 4-17; “Figure 6-7. Transmission Positioning for Driveshaft Alignment” on page 6-2; “Figure 6-8. Tool Application—Use of Alignment Tool Set (T47)” on page 6-3; and pages 6-21 through 6-24, of TM 55-1520-210-23-1 Change 42. This service information contains main driveshaft assembly figures and specifies procedures for the main driveshaft disassembly, and inspecting and correction of its alignment.
The FAA also reviewed “Figure 4-9. Engine Air Inlet Filter Installation” on page 4-16; page 4-17; “Figure 6-7. Transmission Positioning for Driveshaft Alignment” on page 6-2; “Figure 6-8. Tool Application—Use of Alignment Tool Set (T47)” on page 6-3; pages 6-21 through 6-24; and “Figure 6-12.2. Main Driveshaft Installation & Removal Tool” and “Figure 6-12.3. Work Aid Tool Installed on Main Driveshaft” on page 6-27, of TM 55-1520-210-23-1 Change 47. This service information specifies the same procedures as TM 55-1520-210-23-1 Change 42 with various updates throughout.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in
The FAA reviewed DMWR 55-1615-278, for main driveshaft P/N SKCP2281-103, which specifies maintenance, overhaul, repair, assembly, and balance procedures.
The FAA estimates that this AD affects 384 helicopters of U.S. registry. Labor rates are estimated at $85 per work-hour. Based on these numbers, the FAA estimates that operators may incur the following costs in order to comply with this AD.
Determining the total hours TIS of the main driveshaft takes about 0.5 work-hour for an estimated cost of about $43 per helicopter and $16,512 for the U.S. fleet. Removing and inspecting the main driveshaft takes about 4 work-hours for an estimated cost of $340 per helicopter and $130,560 for the U.S. fleet. Inspecting the installed main driveshaft takes about 1 work-hour for an estimated cost of about $85 per helicopter and $32,640 for the U.S. fleet, per inspection cycle. Inspecting the alignment of the main driveshaft installation takes about 2 work-hours for an estimated cost of $170 per helicopter and $65,280 for the U.S. fleet. If required, adjusting the alignment takes about 0.5 work-hour for an estimated cost of $43 per instance. Replacing a main driveshaft takes about 1 work-hour and parts cost about $54,000, for an estimated cost of $54,085 per replacement. Alternatively, overhauling a main driveshaft takes about 1 work-hour for removal and reinstallation and parts cost about $38,000, for an estimated cost of $38,085 per overhaul.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective February 25, 2022.
None.
This AD applies to restricted category Model UH-1H helicopters; current type certificate holders include but are not limited to Arrow Falcon Exporters Inc.; Global Helicopter Technology, Inc.; Hagglund Helicopters, LLC; JJASPP Engineering Services, LLC.; Northwest Rotorcraft, LLC; Overseas Aircraft Support, Inc.; Richards Heavylift Helo, Inc.; Rotorcraft Development Corporation; Southwest Florida Aviation International, Inc.; and Tamarack Helicopters, Inc., with KAflex main driveshaft part number (P/N) SKCP2180-1, SKCP2281-1, SKCP2281-1R, or SKCP2281-103 installed.
Joint Aircraft System Component (JASC) Code: 6310, Engine/Transmission Coupling.
This AD was prompted by multiple reports of failure of the main driveshaft. The unsafe condition, if not addressed, could result in loss of engine power to the transmission and subsequent loss of control of the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Before further flight after the effective date of this AD, determine the total hours time-in-service (TIS) of the main driveshaft. If the total hours TIS of the main driveshaft cannot be determined, use the helicopter's total hours TIS as the total hours TIS of the main driveshaft for the action required by this paragraph.
(i) If the main driveshaft has accumulated less than 5,000 total hours TIS, before exceeding 5,000 total hours TIS, replace the main driveshaft. The main driveshaft may be overhauled in accordance with FAA-approved procedures to accomplish the replacement required by this paragraph.
(ii) If the main driveshaft has accumulated 5,000 or more total hours TIS, before further flight, replace the main driveshaft. The main drive shaft may be overhauled in accordance with FAA-approved procedures to accomplish the replacement required by this paragraph.
(2) Thereafter following paragraph (g)(1) of this AD, replace the main driveshaft before accumulating 5,000 total hours TIS. The main drive shaft may be overhauled in accordance with FAA-approved procedures to accomplish the replacement required by this paragraph.
(3) Within 25 hours TIS after the effective date of this AD, remove main driveshaft P/N SKCP2180-1, SKCP2281-1, SKCP2281-1R, or SKCP2281-103 by following “6-24.3. Removal—Main Driveshaft P/N SKCP2281-103” on page 6-24, including “4-24. Removal—Air Inlet Filters” on page 4-17 and “Figure 4-9. Engine Air Inlet Filter Installation” on page 4-16, of Headquarters, Department of the Army, Aviation Unit and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-1H/X Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 42, dated April 14, 2003 (TM 55-1520-210-23-1 C 42), except where instructed to “refer to figure 6-12.2” in TM 55-1520-210-23-1 C 42, refer to Figure 1 to the introductory text of paragraph (g)(3) of this AD, and where instructed to “see figure 6-12.3” in TM 55-1520-210-23-1 C 42, see Figure 2 to the introductory text of paragraph (g)(3) of this AD, and:
(i) Inspect for any broken, loose, or missing hardware. If there is broken or loose hardware, before further flight, remove the main driveshaft from service. If there is missing hardware, before further flight, replace the main driveshaft. The main drive shaft may be overhauled in accordance with FAA-approved procedures to accomplish the replacement required by this paragraph.
(ii) Visually inspect each flex frame and mount bolt torque stripe (red or yellow) for movement. If there is any torque stripe movement, before further flight, replace the main driveshaft. The main drive shaft may be overhauled in accordance with FAA-approved procedures to accomplish the replacement required by this paragraph.
(iii) Visually inspect each joint for fretting corrosion, which may be indicated by red metallic particles. If there is any grease, oil, or dirt covering a joint, clean the area and visually inspect again. If there is any fretting corrosion, before further flight, replace the main driveshaft. The main drive shaft may be overhauled in accordance with FAA-approved procedures to accomplish the replacement required by this paragraph.
(iv) Inspect the main driveshaft for mechanical damage, corrosion, an edge dent, and nick as shown in Figure 3 to paragraph (g)(3)(iv) of this AD. For the purposes of this inspection, mechanical damage may be indicated by a crack, scratch, or wear; and corrosion may be indicated by corrosion or pitting. If there is a scratch, wear, corrosion, pitting, an edge dent, or a nick within allowable limits, before further flight, repair the main driveshaft in accordance with FAA-approved procedures. If there is a crack, or a scratch, wear, corrosion, pitting, an edge dent, or a nick that exceeds allowable limits,
(4) Before installing the main driveshaft following paragraph (g)(3) of this AD, and with the engine adapter installed in the end of the engine output shaft, inspect the alignment of the main driveshaft installation between the transmission input drive quill coupling and the engine output shaft adapter by following “6-24. Alignment—Main Driveshaft,” paragraphs c. through g. on pages 6-21 through 6-23, including “Figure 6-7. Transmission Positioning for Driveshaft Alignment” on page 6-2 (Figure 6-7), and “Figure 6-8. Tool Application—Use of Alignment Tool Set (T47)” on page 6-3 (Figure 6-8), of TM 55-1520-210-23-1 C 42. If there is misalignment, before further flight, adjust the alignment by following “6-24. Alignment—Main Driveshaft,” paragraphs h. through j. on page 6-23, including Figure 6-7 and Figure 6-8, of TM 55-1520-210-23-1 C 42.
(5) Within 300 hours TIS after the effective date of this AD, and thereafter within intervals not to exceed 300 hours TIS, with the main driveshaft installed, accomplish the actions in paragraphs (g)(3)(i) through (iv) of this AD.
(6) As an optional terminating action for the requirements of this AD, you may install KAflex main driveshaft P/N SKCP3303-1.
(7) As an option to accomplishing the actions by following the specified portions in TM 55-1520-210-23-1 C 42 in paragraphs (g)(3) and (4) of this AD, you may accomplish the actions by following those specified portions in Headquarters, Department of the Army, Aviation Unit and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-1H/X Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 47, dated September 20, 2005 (TM 55-1520-210-23-1 C 47), and disregard exceptions to refer to Figure 1 and see Figure 2 to the introductory text of paragraph (g)(3) of this AD, instead refer to “Figure 6-12.2. Main Driveshaft Installation & Removal Tool” and see “Figure 6-12.3. Work Aid Tool Installed on Main Driveshaft,” on page 6-27 of TM 55-1520-210-23-1 C 47 as instructed in TM 55-1520-210-23-1 C 47.
(1) The Manager, DSCO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (i) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Ameet Shrotriya, Aerospace Engineer, Delegation Oversight Section, DSCO Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5525; email
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Headquarters, Department of the Army, Aviation Unit and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-1H/X Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 42, dated April 14, 2003:
(A) “Figure 4-9. Engine Air Inlet Filter Installation,” page 4-16;
(B) Page 4-17;
(C) “Figure 6-7. Transmission Positioning for Driveshaft Alignment,” page 6-2;
(D) “Figure 6-8. Tool Application—Use of Alignment Tool Set (T47),” page 6-3; and
(E) Pages 6-21 through 6-24.
(ii) Headquarters, Department of the Army, Aviation Unit and Intermediate Maintenance Instructions Army Model UH-1H/V/EH-1H/X Helicopters, Technical Manual TM 55-1520-210-23-1, Change No. 47, dated September 20, 2005:
(A) “Figure 4-9. Engine Air Inlet Filter Installation,” page 4-16;
(B) Page 4-17;
(C) “Figure 6-7. Transmission Positioning for Driveshaft Alignment,” page 6-2;
(D) “Figure 6-8. Tool Application—Use of Alignment Tool Set (T47),” page 6-3;
(E) Pages 6-21 through 6-24; and
(F) “Figure 6-12.2. Main Driveshaft Installation & Removal Tool” and “Figure 6-12.3. Work Aid Tool Installed on Main Driveshaft,” page 6-27.
(3) For service information identified in this AD, contact U.S. Army Materiel Command Logistics Data Analysis Center (USAMC LDAC), ATTN: Equipment Publication Control Officers (EPCOs), Building 3305, Redeye Road, Redstone Arsenal, AL 35898-7466; telephone (256) 955-7716 or 1-866-211-3367; email
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email:
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for all General Electric Company (GE) CF6-80C2A1, CF6-80C2A2, CF6-80C2A3, CF6-80C2A5, CF6-80C2A5F, and CF6-80C2A8 model turbofan engines with an installed left-hand rear mount link assembly, part number (P/N) 1846M23G01. This AD was prompted by the manufacturer reducing the life limit for the affected left-hand rear mount link assembly. This AD requires revising the airworthiness limitations section (ALS) of the existing engine maintenance manual and the operator's existing approved continuous airworthiness maintenance program (CAMP). The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective February 25, 2022.
For service information identified in this final rule, contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215; phone: (513) 552-3272; email:
You may examine the AD docket at
Scott Stevenson, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7132; fax: (781) 238-7199; email:
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all GE CF6-80C2A1, CF6-80C2A2, CF6-80C2A3, CF6-80C2A5, CF6-80C2A5F, and CF6-80C2A8 model turbofan engines with an installed left-hand rear mount link assembly, P/N 1846M23G01. The NPRM published in the
The FAA received comments from one commenter, FedEx Express, who supported the NPRM without change.
The FAA reviewed the relevant data, considered the comments received, and determined that air safety requires adopting the AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, including the removal of the reference to GE CF6-80C2 Engine Manual, GEK92451, this AD is adopted as proposed in the NPRM.
The FAA reviewed GE CF6-80C2 Temporary Revision (TR) 05-0276, dated July 13, 2021 (GE TR 05-0276), and GE CF6-80C2 TR 05-0277, dated July 9, 2021 (GE TR 05-0277). GE TR 05-0276 and GE TR 05-277 provide the new life limit to be updated into the ALS, for the affected left-hand rear mount link assembly, in the existing engine maintenance manual.
The FAA estimates that this AD affects 220 engines installed on airplanes of U.S. registry.
The FAA estimates the following costs to comply with this AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective February 25, 2022.
None.
This AD applies to General Electric Company (GE) CF6-80C2A1, CF6-80C2A2, CF6-80C2A3, CF6-80C2A5, CF6-80C2A5F, and CF6-80C2A8 model turbofan engines with an installed left-hand rear mount link assembly, part number (P/N) 1846M23G01.
Joint Aircraft System Component (JASC) Code 7120, Engine Mount Section.
This AD was prompted by a report from the manufacturer on an updated analysis of stress loads during take-off, which revealed a stress increase with take-off phase loads that were not included at certification. The FAA is issuing this AD to lower the life limit of the left-hand rear mount link assembly and prevent the failure of the engine mount system. The unsafe condition, if not addressed, could result in separation of the engine from the airplane and loss of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 180 days after the effective date of this AD, revise the airworthiness limitations section of the existing engine maintenance manual, and the operator's existing approved continuous airworthiness maintenance program, by reducing the life limit of the left-hand rear mount link assembly, P/N 1846M23G01, from 50,000 flight cycles (FCs) to 23,800 FCs.
(1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ECO Branch, send it to the attention of the person identified in paragraph (i) of this AD. You may email your request to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
For more information about this AD, contact Scott Stevenson, Aviation Safety Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: (781) 238-7132; fax: (781) 238-7199; email:
None.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
The FAA is superseding Airworthiness Directive (AD) 2017-22-06, which applied to certain Bombardier, Inc., Model CL-600-2B16 (601-3A, 601-3R, and 604 Variants) airplanes. AD 2017-22-06 required repetitive inspections for fuel leakage at the engine and auxiliary power unit (APU) fuel pumps, and related investigative and corrective actions if necessary. This AD retains the requirements of AD 2017-22-06, and requires an inspection of the APU, repair if necessary, and modification of the engine electrical fuel pump (EFP) installation. This AD also adds airplanes to the applicability. This AD was prompted by reports of fuel leaks from the electrical connectors and conduits of the engine and APU EFP cartridge/canister, and the development of additional actions to address the root cause of the fuel leaks. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective February 25, 2022.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 25, 2022.
The Director of the Federal Register approved the incorporation by reference of certain other publications listed in this AD as of November 30, 2017 (82 FR 49498, October 26, 2017).
For service information identified in this final rule, contact Bombardier Business Aircraft Customer Response Center, 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514-855-2999; email
You may examine the AD docket on the internet at
Steven Dzierzynski, Aerospace Engineer, Avionics and Electrical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7367; fax 516-794-5531; email
Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued TCCA AD CF-2016-32R4, dated October 13, 2020 (TCCA AD CF-2016-32R4); and TCCA AD CF-2020-38, dated October 13, 2020 (TCCA AD CF-2020-38); (also referred to as the Mandatory Continuing Airworthiness Information, or the MCAI), to correct an unsafe condition for certain Bombardier, Inc., Model CL-600-2B16 (601-3A, 601-3R, and 604 Variants) airplanes. You may examine the MCAI in the AD docket on the internet at
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to supersede AD 2017-22-06, Amendment 39-19086 (82 FR 49498, October 26, 2017) (AD 2017-22-06). AD 2017-22-06 applied to certain Bombardier, Inc., Model CL-600-2B16 (601-3A, 601-3R, and 604 Variants) airplanes. The NPRM published in the
The FAA gave the public the opportunity to participate in developing this final rule. The following presents the comment received on the NPRM and the FAA's response to the comment.
An anonymous commenter requested that the FAA revise the NPRM to allow the use of the latest service bulletin. The commenter stated that the NPRM specifies the use of Bombardier Service Bulletin 604-28-024, dated June 16, 2020, for the actions specified in the NPRM, and that the service bulletin has since been revised to Bombardier Service Bulletin 604-28-024, Revision 1, dated May 28, 2021.
The FAA agrees with the commenter for the reasons provided above. Bombardier Service Bulletin 604-28-024, Revision 01, dated May 28, 2021, adds a figure to clarify the location of a certain drain hole. The service bulletin revision does not add work or affect the technical content of this AD. The FAA has revised the “Related Service Information under 1 CFR part 51” paragraph and figure 2 to paragraph (j) of this AD accordingly. The FAA also has also added paragraph (m)(4) of this AD to allow credit for actions required by paragraph (j) of this AD if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 604-28-024, dated June 16, 2020.
The FAA reviewed the relevant data, considered the comment received, and determined that air safety and the public interest require adopting this final rule with the change described previously and minor editorial changes. The FAA has determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for addressing the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
The FAA also determined that these changes will not increase the economic burden on any operator or increase the scope of this final rule.
Bombardier has issued the following service information, which describes procedures for repetitive general visual inspections and rectifications for any fuel leak from the engine and APU EFP electrical wiring conduit outlets. These documents are distinct since they apply to different airplane serial numbers.
• Bombardier Service Bulletin 604-28-022, Revision 3, dated August 31, 2018.
• Bombardier Service Bulletin 605-28-010, Revision 3, dated August 31, 2018.
• Bombardier Service Bulletin 650-28-001, Revision 3, dated January 3, 2019.
Bombardier has also issued the following service information, which describes procedures for a detailed visual inspection of the APU for any damage or deformations (
• Bombardier Service Bulletin 604-28-024, Revision 01, dated May 28, 2021.
• Bombardier Service Bulletin 605-28-012, dated June 16, 2020.
• Bombardier Service Bulletin 650-28-002, dated June 16, 2020.
This AD also requires Bombardier Service Bulletin 604-28-022, dated October 19, 2015, and Bombardier Service Bulletin 605-28-010, dated October 19, 2015, which the Director of the Federal Register approved for incorporation by reference as of November 30, 2017 (82 FR 49498, October 26, 2017).
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA estimates that this AD affects 128 airplanes of U.S. registry.
The FAA estimates the following costs to comply with this AD:
The FAA estimates the following costs to do any necessary repair that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need this repair:
According to the manufacturer, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators. The FAA does not control warranty coverage for affected operators. As a result, the FAA has included all known costs in the cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective February 25, 2022.
This AD replaces AD 2017-22-06, Amendment 39-19086 (82 FR 49498, October 26, 2017) (AD 2017-22-06).
This AD applies to Bombardier, Inc., Model CL-600-2B16 (601-3A, 601-3R, and 604 Variants) airplanes, certificated in any category, serial numbers 5301 through 5665 inclusive, 5701 through 5990 inclusive, and 6050 through 6163 inclusive.
Air Transport Association (ATA) of America Code 28, Fuel.
This AD was prompted by reports of fuel leaks from the electrical connectors and conduits of the engine and auxiliary power unit (APU) electrical fuel pump (EFP) cartridge/canister, and the development of additional actions to address the root cause of the fuel leaks. The FAA is issuing this AD to address the potential for a fire hazard as a result of fuel leak from the APU EFP electrical conduit in the hot landing light compartment.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2017-22-06, with revised service information and method of compliance provisions. For Model CL-600-2B16 airplanes having serial numbers 5301 through 5665 inclusive: Within 600 flight hours or 12 months, whichever occurs first after November 30, 2017 (the effective date of AD 2017-22-06), do the inspections specified in paragraphs (g)(1) through (3) of this AD, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 604-28-022, dated October 19, 2015, or Bombardier Service Bulletin 604-28-022, Revision 3, dated August 31, 2018. Do all applicable corrective actions before further flight. Repeat the inspections at intervals not to exceed 600 flight hours or 12 months, whichever occurs first. As the effective date of this AD, use Bombardier Service Bulletin 604-28-022, Revision 3, dated August 31, 2018, only.
(1) Do a general visual inspection for traces of fuel coming from the right-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(2) Do a general visual inspection for traces of fuel coming from the left-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(3) Do a general visual inspection for traces of fuel coming from the EFP electrical wiring conduit outlet at the lower body fairing area for engine EFPs and at the right-hand landing light compartment for the APU EFP.
This paragraph restates the requirements of paragraph (h) of AD 2017-22-06, with revised service information and compliance method provisions. For Model CL-600-2B16 airplanes having serial numbers 5701 through 5955 inclusive, 5957, 5960 through 5966 inclusive, 5968 through 5971 inclusive, and 5981: Within 600 flight hours or 12 months, whichever occurs first after November 30, 2017 (the effective date of AD 2017-22-06), do the inspections specified in paragraphs (h)(1) through (3) of this AD, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions in Bombardier Service Bulletin 605-28-010, dated October 19, 2015, or Bombardier Service Bulletin 605-28-010, Revision 3, dated August 31, 2018. Do all applicable related investigative and corrective actions before further flight. Repeat the inspections at intervals not to exceed 600 flight hours or 12 months, whichever occurs first. As of the effective date of this AD, use Bombardier Service Bulletin 605-28-010, Revision 3, dated August 31, 2018, only.
(1) Do a general visual inspection for traces of fuel coming from the right-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(2) Do a general visual inspection for traces of fuel coming from the left-hand engine boost pump at the location of the belly fairing screw (FS412, BL 0.0).
(3) Do a general visual inspection of the right-hand landing light compartment for traces of fuel coming from the APU EFP.
For the airplanes identified in figure 1 to paragraph (i) of this AD: At the applicable compliance time specified in figure 1 to paragraph (i) of this AD, do a general visual inspection for any fuel leak from the engine and APU EFP electrical wiring conduit outlets, in accordance with the Accomplishment Instructions of the applicable service information specified in figure 1 to paragraph (i) of this AD. If any fuel leak is found during the general visual
Within 60 months after the effective date of this AD: Do a detailed visual inspection of the APU for any damage or deformations, and modify the engine EFP installation, in accordance with the Accomplishment Instructions of the applicable service information specified in figure 2 to paragraph (j) of this AD. If any damage or deformations are found during the detailed visual inspection, before further flight, do the repair in accordance with the Accomplishment Instructions of the applicable service information specified in figure 2 to paragraph (j) of this AD.
Where service information identified in this AD specifies to submit certain information to the manufacturer, this AD does not include that requirement.
Accomplishing the actions required by paragraph (j) of this AD terminates all requirements of this AD.
(1) This paragraph provides credit for actions required by paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 604-28-022, dated October 19, 2015, provided that within 4 months or 150 flight hours from the effective date of this AD or within 1 year from the last inspection, whichever occurs first, the actions specified in paragraph (g) are done using Bombardier Service Bulletin 604-28-022, Revision 3, dated August 31, 2018. Bombardier Service Bulletin 604-28-022, dated October 19, 2015, was incorporated by reference in AD 2017-22-06.
(2) This paragraph provides credit for actions required by paragraph (h) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 605-28-010, dated October 19, 2015, provided that within 4 months or 150 flight hours from the effective date of this AD or within 1 year from the last inspection, whichever occurs first, the actions specified in paragraph (h) of this AD are done using Bombardier Service Bulletin 605-28-010, Revision 3, dated August 31, 2018. Bombardier Service Bulletin 605-28-010, dated October 19, 2015, was incorporated by reference in AD 2017-22-06.
(3) This paragraph provides credit for actions required by paragraph (i) of this AD, if those actions were performed before the effective date of this AD using the service information in paragraphs (m)(3)(i) through (iii) of this AD, provided that within 1 year from the last inspection, the actions accomplished in paragraph (i) of this AD are done using Bombardier Service Bulletin 650-28-001, Revision 3, dated January 3, 2019. This service information is not incorporated by reference in this AD.
(i) Bombardier Service Bulletin 650-28-001, dated November 3, 2017.
(ii) Bombardier Service Bulletin 650-28-001, Revision 1, dated May 14, 2018.
(iii) Bombardier Service Bulletin 650-28-001, Revision 2, dated August 31, 2018.
(4) This paragraph provides credit for actions required by paragraph (j) of this AD, if those actions were performed before the effective date of this AD using Bombardier Service Bulletin 604-28-024, dated June 16, 2020. This service information is not incorporated by reference in this AD.
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) TCCA AD CF-2016-32R4, dated October 13, 2020; and TCCA AD CF-2020-38, dated October 13, 2020; for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Steven Dzierzynski, Aerospace Engineer, Avionics and Electrical Systems Section, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; telephone 516-228-7367; fax 516-794-5531; email
(3) Service information identified in this AD that is not incorporated by reference is available at the addresses specified in paragraphs (p)(5) and (6) of this AD.
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(3) The following service information was approved for IBR on February 25, 2022.
(i) Bombardier Service Bulletin 604-28-022, Revision 3, dated August 31, 2018.
(ii) Bombardier Service Bulletin 604-28-024, Revision 01, dated May 28, 2021.
(iii) Bombardier Service Bulletin 605-28-010, Revision 3, dated August 31, 2018.
(iv) Bombardier Service Bulletin 605-28-012, dated June 16, 2020.
(v) Bombardier Service Bulletin 650-28-001, Revision 3, dated January 3, 2019.
(vi) Bombardier Service Bulletin 650-28-002, dated June 16, 2020.
(4) The following service information was approved for IBR on November 30, 2017 (82 FR 49498, October 26, 2017).
(i) Bombardier Service Bulletin 604-28-022, dated October 19, 2015.
(ii) Bombardier Service Bulletin 605-28-010, dated October 19, 2015.
(5) For service information identified in this AD, contact Bombardier Business Aircraft Customer Response Center, 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 1-514-855-2999; email
(6) You may view this service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For information on the availability of this material at the FAA, call 206-231-3195.
(7) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is adopting a new airworthiness directive (AD) for certain Pilatus Aircraft Ltd. (Pilatus) Model PC-24 airplanes. This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as insufficient performance of the fuel drain system that could lead to fire and damage of the airplane. This AD requires modifying the fuel drain pipe routing and installing a drain mast. The FAA is issuing this AD to address the unsafe condition on these products.
This AD is effective February 25, 2022.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 25, 2022.
For service information identified in this final rule, contact Pilatus Aircraft Ltd., CH-6371, Stans, Switzerland; phone: +41 848 24 7 365; email:
You may examine the AD docket at
Doug Rudolph, Aviation Safety Engineer, FAA, General Aviation & Rotorcraft Section, International Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone: (816) 329-4059; fax: (816) 329-4090; email:
The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain serial-numbered Pilatus Model PC-24 airplanes. The NPRM published in the
An occurrence was reported where an insufficient performance of the fuel drain system was detected on certain PC-24 aeroplanes.
This condition, if not corrected, could lead, in case of a fuel leak, to contamination of the inboard rear fuselage, creating a fuel vapour which, in combination with an ignition source, could possibly result in a fire and consequent damage to the aeroplane.
To address this potential unsafe condition, Pilatus Aircraft issued the [service bulletin] SB providing instructions to modify the fuel drain pipe routing and to install a drain mast.
For the reason described above, this [EASA] AD requires modification of the fuel drain system.
In the NPRM, the FAA proposed to require modifying the fuel drain pipe routing and installing a drain mast. The FAA is issuing this AD to address the unsafe condition on these products.
You may examine the MCAI in the AD docket at
The FAA received no comments on the NPRM or on the determination of the costs.
This product has been approved by the aviation authority of another country and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. This AD is adopted as proposed in the NPRM.
The FAA reviewed Pilatus PC-24 Service Bulletin No. 28-003, Revision 1, dated January 23, 2020. This service information specifies procedures for modifying the fuel drain pipe routing and installing a drain mast.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA estimates that this AD will affect 36 airplanes of U.S. registry. The FAA also estimates that it would take about 12 work-hours per airplane to do the modification and installation of this AD. The average labor rate is $85 per work-hour. Required parts would cost about $1,950 per airplane.
Based on these figures, the FAA estimates the cost of this AD on U.S. operators would be $106,920 or $2,970 per airplane.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This airworthiness directive (AD) is effective February 25, 2022.
None.
This AD applies to Pilatus Aircraft Ltd. Model PC-24 airplanes, serial numbers 101 through 184, certificated in any category.
Joint Aircraft System Component (JASC) Code 2830, Fuel Dump System.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as insufficient performance of the fuel drain system that could lead to fire and damage of the airplane. The FAA is issuing this AD to prevent fuel contamination of the inboard rear fuselage. If not addressed, this unsafe condition, in combination with an ignition source, could result in fire and loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 5 months after the effective date of this AD, modify the fuel drain pipe routing and install the drain mast by following paragraphs A. and B. of the Accomplishment Instructions in Pilatus PC-24 Service Bulletin No. 28-003, Revision 1, dated January 23, 2020.
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (i)(1) of this AD and email to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Doug Rudolph, Aviation Safety Engineer, General Aviation & Rotorcraft Section, FAA, General Aviation & Rotorcraft Section, International Validation Branch, 901 Locust, Room 301, Kansas City, MO 64106; phone: (816) 329-4059; fax: (816) 329-4090; email:
(2) Refer to European Union Aviation Safety Agency AD 2020-0252, dated November 12, 2020, for related information. You may examine the MCAI at
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Pilatus PC-24 Service Bulletin No. 28-003, Revision 1, dated January 23, 2020.
(ii) [Reserved]
(3) For service information identified in this AD, contact Pilatus Aircraft Ltd., Customer Support General Aviation, CH-6371 Stans, Switzerland; phone: +41 848 24 7 365; email:
(4) You may review this referenced service information at the FAA, Airworthiness Products Section, Operational Safety Branch, 901 Locust, Kansas City, MO 64106. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email:
Federal Energy Regulatory Commission.
Final rule.
In accordance with the Commission's regulations, the Commission, by its designee, the Executive Director, issues this annual update to the fee schedule in the appendix to the part, which lists per-acre rental fees by county (or other geographic area) for use of government lands by hydropower licensees.
This rule is effective January 21, 2022. The updates to appendix A to part 11, with the fee schedule of per-acre rental fees by county (or other geographic area), are from October 1, 2021, through September 30, 2022 (Fiscal Year 2022).
Raven A. Rodriguez, Financial Management Division, Office of the Executive Director, Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, (202) 502-6276,
Section 11.2 of the Commission's regulations provides a method for computing reasonable annual charges for recompensing the United States for the use, occupancy, and enjoyment of its lands by hydropower licensees.
This final rule is effective January 21, 2022. The provisions of 5 U.S.C. 804, regarding Congressional review of final rules, do not apply to this final rule because the rule concerns agency procedure and practice and will not substantially affect the rights or obligations of non-agency parties. This final rule merely updates the fee schedule published in the Code of Federal Regulations to reflect scheduled adjustments, as provided for in § 11.2 of the Commission's regulations.
Public lands.
By the Executive Director.
In consideration of the foregoing, the Commission amends appendix A to part 11, chapter I, title 18,
16 U.S.C. 792-828c; 42 U.S.C. 7101-7352.
Food and Drug Administration, Department of Health and Human Services (HHS).
Final amendment; final order.
The Food and Drug Administration (FDA, Agency, or we) is classifying the retinal diagnostic software device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the retinal diagnostic software device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
This order is effective January 21, 2022. The classification was applicable on April 11, 2018.
Elvin Ng, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1304, Silver Spring, MD 20993-0002, 240-402-4662,
Upon request, FDA has classified the retinal diagnostic software device as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, by placing the device into a lower device class than the automatic class III assignment.
The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).
FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.
Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).
Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.
Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.
We believe this De Novo classification will enhance patients' access to beneficial innovation. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i)) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.
On January 12, 2018, FDA received IDx, LLC's request for De Novo classification of the IDx-DR. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.
We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.
Therefore, on April 11, 2018, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 886.1100.
FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.
FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.
At the time of classification, retinal diagnostic software devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820, regarding quality system regulation, have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Software verification and validation documentation, based on a comprehensive hazard analysis, must fulfill the following:
(i) Software documentation must provide a full characterization of technical parameters of the software, including algorithm(s).
(ii) Software documentation must describe the expected impact of applicable image acquisition hardware characteristics on performance and associated minimum specifications.
(iii) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.
(iv) Software documentation must include mitigation measures to manage failure of any subsystem components with respect to incorrect patient reports and operator failures.
(2) Clinical performance data supporting the indications for use must be provided, including the following:
(i) Clinical performance testing must evaluate sensitivity, specificity, positive predictive value, and negative predictive value for each endpoint reported for the indicated disease or condition across the range of available device outcomes.
(ii) Clinical performance testing must evaluate performance under anticipated conditions of use.
(iii) Statistical methods must include the following:
(A) Where multiple samples from the same patient are used, statistical analysis must not assume statistical independence without adequate justification.
(B) Statistical analysis must provide confidence intervals for each performance metric.
(iv) Clinical data must evaluate the variability in output performance due to both the user and the image acquisition device used.
(3) A training program with instructions on how to acquire and process quality images must be provided.
(4) Human factors validation testing that evaluates the effect of the training program on user performance must be provided.
(5) A protocol must be developed that describes the level of change in device technical specifications that could significantly affect the safety or effectiveness of the device.
(6) Labeling must include:
(i) Instructions for use, including a description of how to obtain quality images and how device performance is affected by user interaction and user training;
(ii) The type of imaging data used, what the device outputs to the user, and whether the output is qualitative or quantitative;
(iii) Warnings regarding image acquisition factors that affect image quality;
(iv) Warnings regarding interpretation of the provided outcomes, including:
(A) A warning that the device is not to be used to screen for the presence of diseases or conditions beyond its indicated uses;
(B) A warning that the device provides a screening diagnosis only and that it is critical that the patient be advised to receive followup care; and
(C) A warning that the device does not treat the screened disease;
(v) A summary of the clinical performance of the device for each output, with confidence intervals; and
(vi) A summary of the clinical performance testing conducted with the device, including a description of the patient population and clinical environment under which it was evaluated.
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is issuing this final rule to make a technical amendment to the definition of the term “applicable schedule amount” in its regulations. In recent years, OFAC has adjusted its civil monetary penalties (CMPs) as required by the Federal Civil Penalties Inflation Adjustment Act, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. While OFAC's “applicable schedule amount” values are not civil monetary penalties that are required to be adjusted pursuant to such statute, OFAC is updating the definition of the term “applicable schedule amount” so that it will automatically rise with OFAC's CMPs, removing the necessity of updating the applicable schedule amount on an annual basis.
This rule is effective January 21, 2022.
OFAC: Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel.: 202-622-4855; or Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490.
This document and additional information concerning OFAC are available on OFAC's website:
On September 8, 2008, OFAC issued as an interim final rule the “Economic Sanctions Enforcement Guidelines” (Enforcement Guidelines) as appendix A to the Reporting, Procedures and Penalties Regulations at 31 CFR part 501 (73 FR 51933, September 8, 2008). On November 9, 2009, OFAC re-issued as a final rule the Enforcement Guidelines (74 FR 57593, November 9, 2009). OFAC's Enforcement Guidelines provide a general framework for the enforcement of all economic sanctions programs administered by OFAC. Section V.B.2.a.ii. of the Enforcement Guidelines states that the base amount of a proposed civil penalty in a Pre-Penalty Notice shall be the “applicable schedule amount,” subject to certain caps noted in that section, where the case is deemed non-egregious and the apparent violation has come to OFAC's attention by means other than a voluntary self-disclosure. Section I.B. of the Enforcement Guidelines provides a definition of “applicable schedule amount.”
Separately, as required by the Federal Civil Penalties Inflation Adjustment Act (1990 Pub. L. 101-410, 104 Stat. 890; 28 U.S.C. 2461 note), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Pub. L. 114-74, 129 Stat. 599, 28 U.S.C. 2461 note) (the FCPIA Act), OFAC has adjusted its CMPs seven times since the FCPIA Act went into effect on November 2, 2015: An initial catch-up adjustment on August 1, 2016 (81 FR 43070, July 1, 2016); an additional initial catch-up adjustment related to CMPs for failure to comply with a requirement to furnish information, the late filing of a required report, and failure to maintain records that were inadvertently omitted from the August 1, 2016 initial catch-up adjustment on October 5, 2020 (85 FR 54911, September 3, 2020); and annual adjustments on February 10, 2017 (82 FR 10434, February 10, 2017); March 19, 2018 (83 FR 11876, March 19, 2018); June 14, 2019 (84 FR 27714, June 14, 2019); April 9, 2020 (85 FR 19884, April 9, 2020); and March 17, 2021 (86 FR 14534, March 17, 2021).
OFAC's applicable schedule amount values in the Enforcement Guidelines, while not required to be adjusted pursuant to the FCPIA Act, correspond in certain ways with OFAC's CMPs. As a result, OFAC issued final rules on August 11, 2020 (85 FR 48474, August 11, 2020) and April 12, 2021 (86 FR 18895, April 12, 2021) amending the definition of “applicable schedule amount” in section I.B. of appendix A to 31 CFR part 501 to adjust applicable schedule amount values for transactions valued at $200,000 or more to correspond with recent CMP adjustments required by the FCPIA Act.
By a separate rule, OFAC will publish its annual adjustment of CMPs pursuant to the FCPIA Act for 2022. Today, OFAC is amending the definition of “applicable schedule amount” in section I.B. of appendix A to 31 CFR part 501 to automatically adjust the applicable schedule amount value for transactions valued at $200,000 or more as new CMP adjustments are published. Specifically, OFAC is amending section I.B.7. such that in the case of transactions valued at $200,000 or more, the applicable schedule amount is equivalent to the statutory maximum civil penalty per violation of the International Emergency Economic Powers Act (50 U.S.C. 1701-1706, at 1705) listed in section V.B.2.a.v of appendix A to 31 CFR part 501. This change is not required pursuant to the FCPIA Act; however, OFAC is making this change to ensure the applicable schedule amount value continues to correspond appropriately to OFAC's CMPs as the CMPs are adjusted annually pursuant to the FCPIA Act. In addition, OFAC is making technical edits to the authority citation to conform to
Because this final rule imposes no obligations on any person, but only amends OFAC's enforcement policy and procedures based on existing substantive rules, provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Further, this final rule is not a significant regulatory action for purposes of Executive Order 12866 of September 30, 1993, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The Paperwork Reduction Act does not apply because this rule does not impose information collection requirements that would require the approval of the Office of Management and Budget under 44 U.S.C. 3501
Administrative practice and procedure, Banks, Banking, Blocking of assets, Exports, Foreign trade, Licensing, Penalties, Sanctions.
For the reasons set forth in the preamble, OFAC amends 31 CFR part 501 as follows:
8 U.S.C. 1189; 18 U.S.C. 2332d, 2339B; 19 U.S.C. 3901-3913; 21 U.S.C. 1901-1908; 22 U.S.C. 287c, 2370(a), 6009, 6032, 7205, 8501-8551; 31 U.S.C. 321(b); 50 U.S.C. 1701-1706, 4301-4341; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note).
7. The statutory maximum civil penalty per violation of IEEPA listed in section V.B.2.a.v. of this appendix with respect to a transaction valued at $200,000 or more.
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Transnational Criminal Organizations Sanctions Regulations and reissuing them in their entirety to further implement a July 24, 2011 Executive order and a March 15, 2019 Executive order related to transnational criminal organizations. This final rule replaces the regulations that were published in abbreviated form on January 12, 2012 and amended on July 23, 2019, and includes additional interpretive guidance, definitions, general licenses, and other regulatory provisions that will provide further guidance to the public. Due to the number of regulatory sections being updated or added, OFAC is amending and reissuing the Transnational Criminal Organizations Sanctions Regulations in their entirety.
This rule is effective January 21, 2022.
OFAC: Assistant Director for Licensing, 202-622-2480; Assistant Director for Regulatory Affairs, 202-622-4855; or Assistant Director for Sanctions Compliance & Evaluation, 202-622-2490.
This document and additional information concerning OFAC are available on OFAC's website:
On January 12, 2012, OFAC issued the Transnational Criminal Organizations Sanctions Regulations, 31 CFR part 590 (77 FR 1864, January 12, 2012) (the “Regulations”), to implement Executive Order (E.O.) 13581 of July 24, 2011, “Blocking Property of Transnational Criminal Organizations” (76 FR 44757, July 27, 2011), pursuant to authorities delegated to the Secretary of the Treasury in E.O. 13581. The Regulations were initially issued in abbreviated form for the purpose of providing immediate guidance to the public. OFAC amended the Regulations on July 23, 2019 (84 FR 35307, July 23, 2019) to implement E.O. 13863 of March 15, 2019, “Taking Additional Steps to Address the National Emergency With Respect to Significant Transnational Criminal Organizations” (84 FR 10255, March 19, 2019), which amended E.O. 13581. OFAC is amending and reissuing the Regulations as a more comprehensive set of regulations that includes additional interpretive guidance and definitions, general licenses, and other regulatory provisions that will provide further guidance to the public. Due to the number of regulatory sections being updated or added, OFAC is reissuing the Regulations in their entirety.
On July 24, 2011, the President, invoking the authority of,
Section 1(a) of E.O. 13581 blocks, with certain exceptions, all property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any United States person of: (i) The persons listed in the Annex to E.O. 13581; and (ii) any person determined by the Secretary of the Treasury, in consultation with the Attorney General and the Secretary of State: (A) To be a foreign person that constitutes a significant transnational criminal organization; (B) to have materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of any person whose property and interests in property are blocked pursuant to E.O. 13581; or (C) to be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to E.O. 13581. The property and interests in property of the persons described above may not be transferred, paid, exported, withdrawn, or otherwise dealt in.
In Section 1(b) of E.O. 13581, the President determined that the making of donations of certain articles, such as food, clothing, and medicine, intended to be used to relieve human suffering, as specified in section 203(b)(2) of IEEPA (50 U.S.C. 1702(b)(2)), by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to E.O. 13581 would seriously impair the President's ability to deal with the national emergency declared in E.O. 13581. The President therefore prohibited the donation of such items except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to E.O. 13581.
Section 1(c) of E.O. 13581 provides that the prohibition on any transaction or dealing in blocked property or interests in property includes the making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to E.O. 13581, and the receipt of any contribution or provision of funds, goods, or services from any such person.
Section 2 of E.O. 13581 prohibits any transaction by a United States person or within the United States that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in E.O. 13581, as
Section 3 of E.O. 13581 provides definitions for certain terms used in the order. As discussed further below, section 3 of E.O. 13581 was amended by E.O. 13863.
Section 5 of E.O. 13581 authorizes the Secretary of the Treasury, in consultation with the Attorney General and the Secretary of State, to take such actions, including the promulgation of rules and regulations, and to employ all powers granted to the President by IEEPA, as may be necessary to carry out the purposes of E.O. 13581. Section 5 of E.O. 13581 also provides that the Secretary of the Treasury may redelegate any of these functions to other officers and agencies of the U.S. Government.
On March 15, 2019, pursuant to,
In furtherance of the purpose of E.O. 13581, as amended by E.O. 13863 (“amended E.O. 13581”), OFAC is reissuing the Regulations. The Regulations implement targeted sanctions that are directed at persons determined to meet the criteria set forth in § 590.201 of the Regulations, as well as sanctions that may be set forth in any future Executive orders issued pursuant to the national emergency declared in E.O. 13581.
Subpart A of the Regulations clarifies the relation of this part to other laws and regulations. Subpart B of the Regulations implements the prohibitions contained in sections 1 and 2 of amended E.O. 13581, as well as the prohibitions contained in any further Executive orders issued pursuant to the national emergency declared in E.O. 13581.
Sections 590.202 and 590.203 of subpart B detail the effect of transfers of blocked property in violation of the Regulations and set forth the requirement to hold blocked funds, such as currency, bank deposits, or liquidated financial obligations, in interest-bearing blocked accounts. Section 590.204 of subpart B provides that all expenses incident to the maintenance of blocked tangible property shall be the responsibility of the owners and operators of such property, and that such expenses shall not be met from blocked funds, unless otherwise authorized. The section further provides that blocked property may, in OFAC's discretion, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
Section 590.205 of subpart B prohibits any transaction by a U.S. person or within the United States that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in § 590.201 of the Regulations, and any conspiracy formed to violate such prohibitions.
Section 590.206 of subpart B details transactions that are exempt from the prohibitions of the Regulations pursuant to section 203(b)(1) of IEEPA (50 U.S.C. 1702(b)(1)), which relates to personal communications.
In subpart C of the Regulations, new definitions are being added to other key terms used throughout the Regulations. Because these new definitions were inserted in alphabetical order, the definitions that were in the prior abbreviated set of regulations have been renumbered. The definition previously in § 590.316, as incorporated into the Regulations on July 23, 2019 (84 FR 35307, July 23, 2019), is being removed because the term is not used in the Regulations.
Similarly, in subpart D, which contains interpretive sections regarding the Regulations, certain provisions have been renumbered and others added to those in the prior abbreviated set of regulations. Section 590.411 of subpart D explains that the property and interests in property of an entity are blocked if the entity is directly or indirectly owned, whether individually or in the aggregate, 50 percent or more by one or more persons whose property and interests in property are blocked, whether or not the entity itself is incorporated into OFAC's SDN List.
Transactions otherwise prohibited by the Regulations but found to be consistent with U.S. policy may be authorized by one of the general licenses contained in subpart E of the Regulations or by a specific license issued pursuant to the procedures described in subpart E of 31 CFR part 501. General licenses and statements of licensing policy relating to this part also may be available through the Transnational Criminal Organizations sanctions page on OFAC's website:
OFAC is also incorporating several new general licenses into the Regulations, renumbering existing general licenses, and making technical edits to certain existing general licenses. Sections 590.506, 590.508, 590.510, and 590.11 authorize, respectively, certain transactions relating to the investment of certain funds, payments for legal services from funds originating outside the United States, official business of the United States Government, and official activities of certain international organizations and other international entities. Section 590.506 was renumbered as § 590.507 and § 590.507 was renumbered as § 590.509. In § 590.509, OFAC has removed the requirement that the receipt of payment for emergency medical services be specifically licensed.
Subpart F of the Regulations refers to subpart C of part 501 for recordkeeping and reporting requirements. Subpart G of the Regulations describes the civil and criminal penalties applicable to violations of the Regulations, as well as the procedures governing the potential imposition of a civil monetary penalty or issuance of a Finding of Violation. Subpart G also refers to appendix A of part 501 for a more complete description of these procedures.
Subpart H of the Regulations refers to subpart E of part 501 for applicable provisions relating to administrative procedures and contains a delegation of
Because the Regulations involve a foreign affairs function, the provisions of E.O. 12866 of September 30, 1993, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, banking, Blocking of assets, Credit, Foreign trade, Penalties, Reporting and recordkeeping requirements, Transnational Criminal Organizations, Sanctions, Securities, Services.
3 U.S.C. 301; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890, as amended (28 U.S.C. 2461 note); E.O. 13581, 76 FR 44757, 3 CFR, 2011 Comp., p. 260; E.O. 13863, 84 FR 10255, 3 CFR, 2019 Comp., p. 267.
This part is separate from, and independent of, the other parts of this chapter, with the exception of part 501 of this chapter, the recordkeeping and reporting requirements and license application and other procedures of which apply to this part. Actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. Differing foreign policy and national security circumstances may result in differing interpretations of similar language among the parts of this chapter. No license or authorization contained in or issued pursuant to those other parts authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to any other provision of law or regulation authorizes any transaction prohibited by this part. No license or authorization contained in or issued pursuant to this part relieves the involved parties from complying with any other applicable laws or regulations.
(a) All property and interests in property that are in the United States, that come within the United States, or that are or come within the possession or control of any U.S. person of the following persons are blocked and may not be transferred, paid, exported, withdrawn, or otherwise dealt in:
(1) The persons listed in the Annex to E.O. 13581 of July 24, 2011;
(2) Any person determined by the Secretary of the Treasury, in consultation with the Attorney General and the Secretary of State:
(i) To be a foreign person that constitutes a significant transnational criminal organization;
(ii) To have materially assisted, sponsored, or provided financial, material, or technological support for, or goods or services to or in support of, any person whose property and interests in property are blocked pursuant to paragraph (a) of this section; or
(iii) To be owned or controlled by, or to have acted or purported to act for or on behalf of, directly or indirectly, any person whose property and interests in property are blocked pursuant to paragraph (a) of this section.
(b) The prohibitions in paragraph (a) of this section include prohibitions on the following transactions:
(1) The making of any contribution or provision of funds, goods, or services by, to, or for the benefit of any person whose property and interests in property are blocked pursuant to paragraph (a) of this section; and
(2) The receipt of any contribution or provision of funds, goods, or services from any person whose property and interests in property are blocked pursuant to paragraph (a) of this section.
(c) Unless authorized by this part or by a specific license expressly referring to this part, any dealing in securities (or evidence thereof) held within the possession or control of a U.S. person and either registered or inscribed in the name of, or known to be held for the benefit of, or issued by, any person whose property and interests in property are blocked pursuant to paragraph (a) of this section is prohibited. This prohibition includes the transfer (including the transfer on the books of any issuer or agent thereof), disposition, transportation, importation, exportation, or withdrawal of, or the endorsement or guaranty of signatures on, any securities on or after the effective date. This prohibition applies irrespective of the fact that at any time (whether prior to, on, or subsequent to the effective date) the registered or inscribed owner of any such securities may have or might appear to have assigned, transferred, or otherwise disposed of the securities.
(d) The prohibitions in paragraph (a) of this section apply except to the extent provided by statutes, or in regulations, orders, directives, or licenses that may be issued pursuant to this part, and notwithstanding any contract entered into or any license or permit granted prior to the effective date.
(e) All transactions prohibited pursuant to any Executive order issued after March 15, 2019 pursuant to the national emergency declared in E.O. 13581 of July 24, 2011, are prohibited pursuant to this part.
The names of persons listed in, or designated or identified pursuant to, E.O. 13581; E.O. 13581, as amended by E.O. 13863 of March 15, 2019 (“amended E.O. 13581”); or any further Executive orders issued pursuant to the national emergency declared in E.O. 13581, whose property and interests in property therefore are blocked pursuant to this section, are published in the
The International Emergency Economic Powers Act (50 U.S.C. 1701-1706), in Section 203 (50 U.S.C. 1702), authorizes the blocking of property and interests in property of a person during the pendency of an investigation. The names of persons whose property and interests in property are blocked pending investigation pursuant to this section also are published in the
Sections 501.806 and 501.807 of this chapter describe the procedures to be followed by persons seeking, respectively, the unblocking of funds that they believe were blocked due to mistaken identity, or administrative reconsideration of their status as persons whose property and interests in property are blocked pursuant to this section.
(a) Any transfer after the effective date that is in violation of any provision of this part or of any regulation, order, directive, ruling, instruction, or license issued pursuant to this part, and that involves any property or interest in property blocked pursuant to § 590.201, is null and void and shall not be the basis for the assertion or recognition of any interest in or right, remedy, power, or privilege with respect to such property or interest in property.
(b) No transfer before the effective date shall be the basis for the assertion or recognition of any right, remedy, power, or privilege with respect to, or any interest in, any property or interest in property blocked pursuant to § 590.201, unless the person who holds or maintains such property, prior to that date, had written notice of the transfer or by any written evidence had recognized such transfer.
(c) Unless otherwise provided, a license or other authorization issued by OFAC before, during, or after a transfer shall validate such transfer or make it enforceable to the same extent that it would be valid or enforceable but for the provisions of this part and any regulation, order, directive, ruling, instruction, or license issued pursuant to this part.
(d) Transfers of property that otherwise would be null and void or unenforceable by virtue of the provisions of this section shall not be deemed to be null and void or unenforceable as to any person with whom such property is or was held or maintained (and as to such person only) in cases in which such person is able to establish to the satisfaction of OFAC each of the following:
(1) Such transfer did not represent a willful violation of the provisions of this part by the person with whom such property is or was held or maintained (and as to such person only);
(2) The person with whom such property is or was held or maintained did not have reasonable cause to know or suspect, in view of all the facts and circumstances known or available to such person, that such transfer required a license or authorization issued pursuant to this part and was not so licensed or authorized, or, if a license or authorization did purport to cover the transfer, that such license or authorization had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained; and
(3) The person with whom such property is or was held or maintained filed with OFAC a report setting forth in full the circumstances relating to such transfer promptly upon discovery that:
(i) Such transfer was in violation of the provisions of this part or any regulation, ruling, instruction, license, or other directive or authorization issued pursuant to this part;
(ii) Such transfer was not licensed or authorized by OFAC; or
(iii) If a license did purport to cover the transfer, such license had been obtained by misrepresentation of a third party or withholding of material facts or was otherwise fraudulently obtained.
(e) The filing of a report in accordance with the provisions of paragraph (d)(3) of this section shall not be deemed evidence that the terms of paragraphs (d)(1) and (2) of this section have been satisfied.
(f) Unless licensed pursuant to this part, any attachment, judgment, decree, lien, execution, garnishment, or other judicial process is null and void with respect to any property or interest in property blocked pursuant to § 590.201.
(a) Except as provided in paragraph (e) or (f) of this section, or as otherwise directed or authorized by OFAC, any U.S. person holding funds, such as currency, bank deposits, or liquidated financial obligations, subject to § 590.201 shall hold or place such funds in a blocked interest-bearing account located in the United States.
(b)(1) For the purposes of this section, the term
(i) In a federally insured U.S. bank, thrift institution, or credit union, provided the funds are earning interest at rates that are commercially reasonable; or
(ii) With a broker or dealer registered with the Securities and Exchange Commission under the Securities Exchange Act of 1934 (15 U.S.C. 78a
(2) Funds held or placed in a blocked account pursuant to paragraph (a) of this section may not be invested in instruments the maturity of which exceeds 180 days.
(c) For the purposes of this section, a rate is commercially reasonable if it is the rate currently offered to other depositors on deposits or instruments of comparable size and maturity.
(d) For the purposes of this section, if interest is credited to a separate blocked account or subaccount, the name of the account party on each account must be the same.
(e) Blocked funds held in instruments the maturity of which exceeds 180 days at the time the funds become subject to § 590.201 may continue to be held until maturity in the original instrument, provided any interest, earnings, or other proceeds derived therefrom are paid into a blocked interest-bearing account in accordance with paragraph (a) or (f) of this section.
(f) Blocked funds held in accounts or instruments outside the United States at the time the funds become subject to § 590.201 may continue to be held in the same type of accounts or instruments, provided the funds earn interest at rates that are commercially reasonable.
(g) This section does not create an affirmative obligation for the holder of blocked tangible property, such as real or personal property, or of other blocked property, such as debt or equity securities, to sell or liquidate such property. However, OFAC may issue licenses permitting or directing such sales or liquidation in appropriate cases.
(h) Funds blocked pursuant to § 590.201 may not be held, invested, or reinvested in a manner that provides financial or economic benefit or access to any person whose property and interests in property are blocked pursuant to § 590.201, nor may their holder cooperate in or facilitate the pledging or other attempted use as collateral of blocked funds or other assets.
(a) Except as otherwise authorized, and notwithstanding the existence of any rights or obligations conferred or imposed by any international agreement or contract entered into or any license or permit granted prior to the effective date, all expenses incident to the maintenance of tangible property blocked pursuant to § 590.201 shall be the responsibility of the owners or operators of such property, which expenses shall not be met from blocked funds.
(b) Property blocked pursuant to § 590.201 may, in the discretion of OFAC, be sold or liquidated and the net proceeds placed in a blocked interest-bearing account in the name of the owner of the property.
(a) Any transaction on or after the effective date that evades or avoids, has the purpose of evading or avoiding, causes a violation of, or attempts to violate any of the prohibitions set forth in this part is prohibited.
(b) Any conspiracy formed to violate the prohibitions set forth in this part is prohibited.
The prohibitions contained in this part do not apply to any postal, telegraphic, telephonic, or other personal communication that does not involve the transfer of anything of value.
The definitions in this subpart apply throughout the entire part.
The terms
(a) The term
(1) With respect to a person whose property and interests in property are blocked pursuant to § 590.201(a)(1), 12:01 a.m. eastern daylight time July 25, 2011; and
(2) With respect to a person whose property and interests in property are otherwise blocked pursuant to § 590.201, the earlier of the date of actual or constructive notice that such person's property and interests in property are blocked.
(b) For the purposes of this section,
The term
The term
The term
Except as otherwise provided in this part, the term
(a) Except as otherwise provided in this part, the term
(b) The term
(c) The term
The term
The term
The terms
The term
The term
The term
The term
The term
(a) Reference to any section in this part is a reference to the same as currently amended, unless the reference includes a specific date.
(b) Reference to any ruling, order, instruction, direction, or license issued pursuant to this part is a reference to the
Unless otherwise specifically provided, any amendment, modification, or revocation of any provision in or appendix to this part or chapter or of any order, regulation, ruling, instruction, or license issued by OFAC does not affect any act done or omitted, or any civil or criminal proceeding commenced or pending, prior to such amendment, modification, or revocation. All penalties, forfeitures, and liabilities under any such order, regulation, ruling, instruction, or license continue and may be enforced as if such amendment, modification, or revocation had not been made.
(a) Whenever a transaction licensed or authorized by or pursuant to this part results in the transfer of property (including any property interest) away from a person whose property and interests in property are blocked pursuant to § 590.201, such property shall no longer be deemed to be property blocked pursuant to § 590.201, unless there exists in the property another interest that is blocked pursuant to § 590.201, the transfer of which has not been effected pursuant to license or other authorization.
(b) Unless otherwise specifically provided in a license or authorization issued pursuant to this part, if property (including any property interest) is transferred or attempted to be transferred to a person whose property and interests in property are blocked pursuant to § 590.201, such property shall be deemed to be property in which such person has an interest and therefore blocked.
(a) Any transaction ordinarily incident to a licensed transaction and necessary to give effect thereto is also authorized, except:
(1) An ordinarily incident transaction, not explicitly authorized within the terms of the license, by or with a person whose property and interests in property are blocked pursuant to § 590.201; or
(2) An ordinarily incident transaction, not explicitly authorized within the terms of the license, involving a debit to a blocked account or a transfer of blocked property.
(b) For example, a license authorizing a person to complete a securities sale involving Company A, whose property and interests in property are blocked pursuant to § 590.201, also authorizes other persons to engage in activities that are ordinarily incident and necessary to complete the sale, including transactions by the buyer, broker, transfer agents, and banks, provided that such other persons are not themselves persons whose property and interests in property are blocked pursuant to § 590.201.
(a) The prohibitions contained in § 590.201 apply to services performed in the United States or by U.S. persons, wherever located:
(1) On behalf of or for the benefit of any person whose property and interests in property are blocked pursuant to § 590.201; or
(2) With respect to property interests of any person whose property and interests in property are blocked pursuant to § 590.201.
(b) The prohibitions on transactions contained in § 590.201 apply to services received in the United States or by U.S. persons, wherever located, where the service is performed by or at the direction of, any person whose property and interests in property are blocked pursuant to § 590.201.
(c) For example, U.S. persons may not, except as authorized by or pursuant to this part, provide legal, accounting, financial, brokering, freight forwarding, transportation, public relations, or other services to a person whose property and interests in property are blocked pursuant to § 590.201, or negotiate with or enter into contracts signed by a person whose property and interests in property are blocked pursuant to § 590.201.
The prohibitions in § 590.201 on transactions or dealings involving blocked property, as defined in § 590.301, apply to transactions by any U.S. person in a location outside the United States.
Pursuant to § 590.201, no debits may be made to a blocked account to pay obligations to U.S. persons or other persons, except as authorized by or pursuant to this part.
Unless specifically authorized by OFAC pursuant to this part, no charitable contribution of funds, goods, services, or technology, including contributions to relieve human suffering, such as food, clothing, or medicine, may be made by, to, or for the benefit of, or received from, a person whose property and interests in property are blocked pursuant to § 590.201. For the purposes of this part, a contribution is made by, to, or for the benefit of, or received from, a person whose property and interests in property are blocked pursuant to § 590.201 if made by, to, or in the name of, or received from or in the name of, such a person; if made by, to, or in the name of, or received from or in the name of, an entity or individual acting for or on behalf of, or owned or controlled by, such a person; or if made in an attempt to violate, to evade, or to avoid the bar on the provision of contributions by, to, or for the benefit of such a person, or the receipt of contributions from such a person.
The prohibition in § 590.201 on dealing in property subject to that section prohibits U.S. financial institutions from performing under any existing credit agreements, including charge cards, debit cards, or other credit facilities issued by a financial institution to a person whose property and interests in property are blocked pursuant to § 590.201.
A setoff against blocked property (including a blocked account), whether by a U.S. financial institution or other U.S. person, is a prohibited transfer under § 590.201 if effected after the effective date.
Persons whose property and interests in property are blocked pursuant to § 590.201 have an interest in all property and interests in property of an entity in which such persons directly or indirectly own, whether individually or in the aggregate, a 50 percent or greater
For provisions relating to licensing procedures, see part 501, subpart E, of this chapter. Licensing actions taken pursuant to part 501 of this chapter with respect to the prohibitions contained in this part are considered actions taken pursuant to this part. General licenses and statements of licensing policy relating to this part also may be available through the Transnational Criminal Organizations sanctions page on OFAC's website:
(a) No license or other authorization contained in this part, or otherwise issued by OFAC, authorizes or validates any transaction effected prior to the issuance of such license or other authorization, unless specifically provided in such license or authorization.
(b) No regulation, ruling, instruction, or license authorizes any transaction prohibited under this part unless the regulation, ruling, instruction, or license is issued by OFAC and specifically refers to this part. No regulation, ruling, instruction, or license referring to this part shall be deemed to authorize any transaction prohibited by any other part of this chapter unless the regulation, ruling, instruction, or license specifically refers to such part.
(c) Any regulation, ruling, instruction, or license authorizing any transaction prohibited under this part has the effect of removing a prohibition contained in this part from the transaction, but only to the extent specifically stated by its terms. Unless the regulation, ruling, instruction, or license otherwise specifies, such an authorization does not create any right, duty, obligation, claim, or interest in, or with respect to, any property that would not otherwise exist under ordinary principles of law.
(d) Nothing contained in this part shall be construed to supersede the requirements established under any other provision of law or to relieve a person from any requirement to obtain a license or other authorization from another department or agency of the U.S. Government in compliance with applicable laws and regulations subject to the jurisdiction of that department or agency. For example, exports of goods, services, or technical data that are not prohibited by this part or that do not require a license by OFAC nevertheless may require authorization by the U.S. Department of Commerce, the U.S. Department of State, or other agencies of the U.S. Government.
(e) No license or other authorization contained in or issued pursuant to this part authorizes transfers of or payments from blocked property or debits to blocked accounts unless the license or other authorization explicitly authorizes the transfer of or payment from blocked property or the debit to a blocked account.
(f) Any payment relating to a transaction authorized in or pursuant to this part that is routed through the U.S. financial system should reference the relevant OFAC general or specific license authorizing the payment to avoid the blocking or rejection of the transfer.
OFAC reserves the right to exclude any person, property, transaction, or class thereof from the operation of any license or from the privileges conferred by any license. OFAC also reserves the right to restrict the applicability of any license to particular persons, property, transactions, or classes thereof. Such actions are binding upon actual or constructive notice of the exclusions or restrictions.
Any payment of funds or transfer of credit in which a person whose property and interests in property are blocked pursuant to § 590.201 has any interest that comes within the possession or control of a U.S. financial institution must be blocked in an account on the books of that financial institution. A transfer of funds or credit by a U.S. financial institution between blocked accounts in its branches or offices is authorized, provided that no transfer is made from an account within the United States to an account held outside the United States, and further provided that a transfer from a blocked account may be made only to another blocked account held in the same name.
(a) A U.S. financial institution is authorized to debit any blocked account held at that financial institution in payment or reimbursement for normal service charges owed it by the owner of that blocked account.
(b) As used in this section, the term
Subject to the requirements of § 590.203, U.S. financial institutions are authorized to invest and reinvest assets blocked pursuant to § 590.201, subject to the following conditions:
(a) The assets representing such investments and reinvestments are credited to a blocked account or subaccount that is held in the same name at the same U.S. financial institution, or within the possession or control of a U.S. person, but funds shall not be transferred outside the United States for this purpose;
(b) The proceeds of such investments and reinvestments shall not be credited to a blocked account or subaccount under any name or designation that differs from the name or designation of the specific blocked account or subaccount in which such funds or securities were held; and
(c) No immediate financial or economic benefit accrues (
(a) The provision of the following legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 590.201 is authorized, provided that any receipt of payment of professional fees and reimbursement of incurred expenses must be authorized pursuant to § 590.508, which authorizes certain payments for legal services from funds originating outside the United States; via specific license; or otherwise pursuant to this part:
(1) Provision of legal advice and counseling on the requirements of and
(2) Representation of persons named as defendants in or otherwise made parties to legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(3) Initiation and conduct of legal, arbitration, or administrative proceedings before any U.S. federal, state, or local court or agency;
(4) Representation of persons before any U.S. federal, state, or local court or agency with respect to the imposition, administration, or enforcement of U.S. sanctions against such persons; and
(5) Provision of legal services in any other context in which prevailing U.S. law requires access to legal counsel at public expense.
(b) The provision of any other legal services to or on behalf of persons whose property and interests in property are blocked pursuant to § 590.201, not otherwise authorized in this part, requires the issuance of a specific license.
(c) U.S. persons do not need to obtain specific authorization to provide related services, such as making filings and providing other administrative services, that are ordinarily incident to the provision of services authorized by paragraph (a) of this section. Additionally, U.S. persons who provide services authorized by paragraph (a) of this section do not need to obtain specific authorization to contract for related services that are ordinarily incident to the provision of those legal services, such as those provided by private investigators or expert witnesses, or to pay for such services.
(d) Entry into a settlement agreement or the enforcement of any lien, judgment, arbitral award, decree, or other order through execution, garnishment, or other judicial process purporting to transfer or otherwise alter or affect property or interests in property blocked pursuant to § 590.201 is prohibited unless licensed pursuant to this part.
Pursuant to part 501, subpart E, of this chapter, U.S. persons seeking administrative reconsideration or judicial review of their designation or the blocking of their property and interests in property may apply for a specific license from OFAC to authorize the release of certain blocked funds for the payment of professional fees and reimbursement of incurred expenses for the provision of such legal services where alternative funding sources are not available.
(a)
(i) A source within the United States;
(ii) Any source, wherever located, within the possession or control of a U.S. person; or
(iii) Any individual or entity, other than the person on whose behalf the legal services authorized pursuant to § 590.507(a) are to be provided, whose property and interests in property are blocked pursuant to any part of this chapter or any Executive order or statute.
(2) Nothing in paragraph (a) of this section authorizes payments for legal services using funds in which any other person whose property and interests in property are blocked pursuant to § 590.201, any other part of this chapter, or any Executive order or statute has an interest.
(b)
(i) The individual or entity from whom the funds originated and the amount of funds received; and
(ii) If applicable:
(A) The names of any individuals or entities providing related services to the U.S. person receiving payment in connection with authorized legal services, such as private investigators or expert witnesses;
(B) A general description of the services provided; and
(C) The amount of funds paid in connection with such services.
(2) The reports, which must reference this section, are to be submitted to OFAC using one of the following methods:
(i)
(ii)
The provision and receipt of nonscheduled emergency medical services that are prohibited by this part are authorized.
All transactions prohibited by this part that are for the conduct of the official business of the United States Government by employees, grantees, or contractors thereof are authorized.
All transactions prohibited by this part that are for the conduct of the official business of the following entities by employees, grantees, or contractors thereof are authorized:
(a) The United Nations, including its Programmes, Funds, and Other Entities and Bodies, as well as its Specialized Agencies and Related Organizations;
(b) The International Centre for Settlement of Investment Disputes (ICSID) and the Multilateral Investment Guarantee Agency (MIGA);
(c) The African Development Bank Group, the Asian Development Bank, the European Bank for Reconstruction and Development, and the Inter-American Development Bank Group (IDB Group), including any fund entity administered or established by any of the foregoing; and
(d) The International Committee of the Red Cross and the International Federation of Red Cross and Red Crescent Societies.
For provisions relating to required records and reports, see part 501, subpart C, of this chapter. Recordkeeping and reporting requirements imposed by part 501 of this chapter with respect to the prohibitions contained in this part are considered requirements arising pursuant to this part.
(a) Section 206 of the International Emergency Economic Powers Act (50 U.S.C. 1705) (IEEPA) is applicable to violations of the provisions of any license, ruling, regulation, order, directive, or instruction issued by or pursuant to the direction or authorization of the Secretary of the
(1) A civil penalty not to exceed the amount set forth in section 206 of IEEPA may be imposed on any person who violates, attempts to violate, conspires to violate, or causes a violation of any license, order, regulation, or prohibition issued under IEEPA.
(2) IEEPA provides for a maximum civil penalty not to exceed the greater of $311,562 or an amount that is twice the amount of the transaction that is the basis of the violation with respect to which the penalty is imposed.
(3) A person who willfully commits, willfully attempts to commit, willfully conspires to commit, or aids or abets in the commission of a violation of any license, order, regulation, or prohibition may, upon conviction, be fined not more than $1,000,000, or if a natural person, be imprisoned for not more than 20 years, or both.
(b)(1) The civil penalties provided in IEEPA are subject to adjustment pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, as amended, 28 U.S.C. 2461 note).
(2) The criminal penalties provided in IEEPA are subject to adjustment pursuant to 18 U.S.C. 3571.
(c) Pursuant to 18 U.S.C. 1001, whoever, in any matter within the jurisdiction of the executive, legislative, or judicial branch of the Government of the United States, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact; or makes any materially false, fictitious, or fraudulent statement or representation; or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry shall be fined under title 18, United States Code, imprisoned, or both.
(d) Violations of this part may also be subject to other applicable laws.
(a)
(b)
(2)
(i)
(ii)
(3)
(c)
(d)
(e)
If, after considering any written response to the Pre-Penalty Notice and any relevant facts, OFAC determines that there was a violation by the alleged violator named in the Pre-Penalty Notice and that a civil monetary penalty is appropriate, OFAC may issue a Penalty Notice to the violator containing a determination of the violation and the imposition of the monetary penalty. For additional details concerning issuance of a Penalty Notice, see appendix A to part 501 of this chapter. The issuance of the Penalty Notice shall constitute final agency action. The violator has the right to seek judicial review of that final agency action in federal district court.
In the event that the violator does not pay the penalty imposed pursuant to this part or make payment arrangements acceptable to OFAC, the matter may be referred for administrative collection measures by the Department of the Treasury or to the United States Department of Justice for appropriate action to recover the penalty in a civil suit in a federal district court.
(a)
(i) Determines that there has occurred a violation of any provision of this part, or a violation of the provisions of any license, ruling, regulation, order, directive, or instruction issued by or pursuant to the direction or authorization of the Secretary of the Treasury pursuant to this part or otherwise under the International Emergency Economic Powers Act (50 U.S.C. 1701
(ii) Considers it important to document the occurrence of a violation; and
(iii) Based on the Guidelines contained in appendix A to part 501 of this chapter, concludes that an administrative response is warranted but that a civil monetary penalty is not the most appropriate response.
(2) An initial Finding of Violation shall be in writing and may be issued whether or not another agency has taken any action with respect to the matter. For additional details concerning issuance of a Finding of Violation, see appendix A to part 501 of this chapter.
(b)
(2)
(i)
(ii)
(3)
(4)
(c)
(2)
A determination by OFAC that a final Finding of Violation is not warranted does not preclude OFAC from pursuing other enforcement actions consistent with the Guidelines contained in appendix A to part 501 of this chapter.
(d)
For license application procedures and procedures relating to amendments, modifications, or revocations of licenses; administrative decisions; rulemaking; and requests for documents pursuant to the Freedom of Information and Privacy Acts (5 U.S.C. 552 and 552a), see part 501, subpart E, of this chapter.
Any action that the Secretary of the Treasury is authorized to take pursuant to E.O. 13581 of July 24, 2011, as amended by E.O. 13863 of March 15, 2019, and any further Executive orders relating to the national emergency declared in E.O. 13581, may be taken by the Director of OFAC or by any other person to whom the Secretary of the Treasury has delegated authority so to act.
For approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) of information collections relating to recordkeeping and reporting requirements, licensing procedures, and other procedures, see § 501.901 of this chapter. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.
Coast Guard, Department of Homeland Security (DHS).
Final rule.
This final rule makes non-substantive technical, organizational, and conforming amendments to existing Coast Guard regulations. This rule is a continuation of our practice of periodically issuing rules to keep our regulations up-to-date and accurate.
This final rule is effective January 21, 2022.
To view documents mentioned in this preamble as being available in the docket, go to
For information about this document call or email Victoria Phoenix, Coast Guard; telephone 202-372-3744, email
We did not publish a notice of proposed rulemaking for this rule. Under Title 5 of the United States Code (U.S.C.), Section 553(b)(A), the Coast Guard finds that this final rule is exempt from notice and public comment rulemaking requirements because these changes involve rules of agency organization, procedure, or practice. In addition, the Coast Guard finds that notice and comment procedures are unnecessary for this final rule under 5 U.S.C. 553(b)(B), as this rule consists of only technical and editorial corrections and these changes will have no substantive effect on the public. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this final rule effective upon publication in the
This final rule, which becomes effective on January 21, 2022, makes technical and editorial corrections throughout titles 33 and 46 of the Code of Federal Regulations (CFR). These changes are necessary to update authority citations, correct errors, update contact information, and make other non-substantive amendments that improve the clarity of the CFR. This rule does not create or change any substantive requirements.
This final rule is issued under the authority of 5 U.S.C. 552(a), 14 U.S.C. 102 and 503; the Department of Homeland Security's (DHS) DHS Delegation No. 00170.1, Revision No. 01.2; and authorities listed at the end of this rule for each CFR part this rule amends.
The Coast Guard periodically issues technical, organizational, and conforming amendments to existing regulations in titles 33 and 46 of the CFR. These technical amendments provide the public with accurate and current regulatory information, but do not change the effect of any Coast Guard regulations on the public.
This rule updates the authority citations in 33 CFR parts 6, 62, 151, 160, and 173, and 46 CFR parts 4, 5, 7, 11, 13, 15, 31, 67, 71, 91, 107, 126, 144, 147, 172, and 189. On December 4, 2018, Congress enacted the Frank LoBiondo Coast Guard Authorization Act of 2018 (Authorization Act), Public Law 115-282, 132 Stat. 4192. The Authorization Act redesignated multiple provisions within Titles 14, 33, 46, and 50 of the U.S. Code (U.S.C.), without substantive change, in an effort to reorganize these titles. The Coast Guard often uses the affected statutory provisions as authority for issuing regulations related to maritime safety and security. This rule updates statutory authority citations that were inadvertently omitted from updating when the Coast Guard redesignated statutory authorities throughout titles 33 and 46 of the CFR in response to the Authorization Act (85 FR 58268, Sept. 18, 2020).
This rule also corrects errors in the authority citations for 33 CFR part 160 and 46 CFR part 67. The updates will correct the omission in 33 CFR part 160 of the word “Chapter” when referring to authority deriving from Title 46 U.S.C Chapter 701 (46 U.S.C. 70101-70132). Also, we are moving the reference to “46 U.S.C. 70011” in the first sentence of the part 160 citation to the second sentence, where it was meant to replace “33 U.S.C. 1225,” which previously appeared in the second sentence. The second sentence listed additional authorities for subpart C of part 160. For 46 CFR part 67, we are correcting a reference to “4 U.S.C. 664” that was intended to reference 14 U.S.C. 664.
Finally, this rule updates the authority citations in 33 CFR subpart 1.07, 33 CFR parts 62, 151, 160, and 173, and 46 CFR parts 4, 5, 7, 11, 13, 15, 31, 67, 71, 91, 107, 126, 144, 147, 172, and 189 to reflect the adoption of Revision No. 01.2 for DHS Delegation 00170.1 and to use the preferred terminology for this delegation.
In § 1.07-5(c), this rule amends the definition of “issuing officer” by adding qualified civilians to the list of Coast Guard personnel who may issue a notice of violation (NOV). Previously, the definition only provided that Coast Guard commissioned, warrant, or petty officers could issue NOVs. These officers do investigate potential violations; however, an increasing number of investigating officers are civilian employees of the Coast Guard. These civilians have the same training and apply the same policies as uniformed issuing officers. Adding qualified civilians to the definition of “issuing officer” will not change the frequency or type of NOV issued. Revising the CFR to add qualified civilians is a matter of agency
In § 6.04-1, this rule adds new paragraph (d) to direct readers to the appeal mechanism for decisions and actions by a Captain of the Port in 33 CFR 160.7. This provision does not modify the appeal mechanism in any way, but is intended as a convenience for readers who may not expect the appeals process for 33 CFR part 6 actions to be located in 33 CFR 160.7.
In § 62.52(b), this rule updates the reference to “real” Automatic Identification System (AIS) Aids to Navigation (AtoN) “physically fitted to the AtoN” to a “physical” AIS “fitted to the AtoN,” in keeping with an internationally agreed upon lexicon change.
In § 151.66(c)(3)(iv), this rule removes the entire paragraph governing keeping records and reporting of the discharge of bulk dry cargo residue on the Great Lakes using Coast Guard Form CG-33. The requirement to use Form CG-33 and submit quarterly reports to the Coast Guard expired on February 28, 2015, but unclear wording caused confusion and unnecessary reporting burdens on Great Lakes vessel owners and operators. There is no longer a requirement to use this specific form or submit it to the Coast Guard, but the recordkeeping requirement remains in force. The Coast Guard's Office of Operating and Environmental Standards has published a Maritime Commons blog post and worked with the Coast Guard's Ninth District to remind U.S. and Canadian vessel owners to communicate this to their employees. This rule also redesignates existing § 151.66(c)(3)(v) as § 151.66(c)(3)(iv), and amends it to remove the reference to Form CG-33. The required record may be in any written format.
In § 173.57, this rule removes paragraph (b) governing the required content of a casualty report filed prior to January 1, 2017, as that date has passed and the paragraph is no longer relevant. Additionally, we have removed the January 1, 2017, date from the existing paragraph (c) and redesignated that paragraph as paragraph (b).
In § 4.40-5(d)(3), this rule revises the definition of “major marine casualty” to apply to property damage initially estimated at $2,000,000 or more, rather than $500,000 as provided in the current regulations. This new language reflects Section 211 of the Save Our Seas Act of 2018 (Pub. L. 115-265, 132 Stat. 3742), which amended section 6101(i)(3) of Title 46, U.S.C., to increase the dollar amount for property damage to qualify a casualty involving a vessel as a “major marine casualty” from $500,000 to $2,000,000.
In § 5.713(b), this rule amends the mailing address for appeals to the National Transportation Safety Board to allow appeal briefs and communications to be sent directly to the Suspension and Revocation National Center of Expertise (S&R NCOE) office located in Martinsburg, West Virginia. The address change will not impact the designation of the Chief Counsel of the Coast Guard as the Commandant's representative in these matters. In accordance with Coast Guard policy, the Chief Counsel has attorneys detailed to the S&R NCOE office in Martinsburg, West Virginia office as primary contacts for suspension and revocation appellate matters. Changing the address to the Martinsburg, West Virginia office will ensure all written and electronic correspondence is received in a timely manner.
In § 7.30, this rule reflects the disestablishment of Ambrose Light and the conversion of Highlands Light to a Private Aid. Additionally, this rule provides specific coordinates and (where applicable) Light List Numbers for East Rockaway Inlet Breakwater Light, the former Ambrose Light, and Highlands Light.
In § 11.410(c), this rule corrects an error introduced in the 2013 Implementation of the Amendments to the International Convention on Standards of Training, Certification, and Watchkeeping for Seafarers, 1978, and Changes to National Endorsements final rule (78 FR 77796, December 24, 2013) (STCW final rule) to limiting an officer's endorsement obtained with an orally assisted examination to vessels of 200 gross register tonnage (GRT), rather than 500 GRT as currently indicated in paragraph (c). The Coast Guard's intent can be clearly seen in current § 11.201(j)(i), which provides that “any applicant for a deck or engineer officer endorsement limited to vessels less than 200 GRT, or an officer endorsement limited to uninspected fishing industry vessels, may request an orally assisted examination instead of any written or other textual examination.” Conforming § 11.401(c) with § 11.201(j)(i) will eliminate any confusion with the endorsements.
In § 11.711(c), this rule replaces references to required pilot experience on vessels of 1,600 GRT or 3,000 “gross tonnage” (GT) with reference to 1,600 “gross register tonnage” (GRT) only. In the STCW final rule, the Coast Guard adopted the convention that it would use GRT when discussing national endorsements and GT when discussing Standards of Training, Certification, and Watchkeeping for Seafarers endorsements. In the Correcting Amendments to the STCW final rule, the Coast Guard decided to revert to the prior text of the 2013 rule, but omitted the convention of solely using GRT for national endorsements and reverted to the prior text without editing the tonnage to 1,600 GRT. As a result, the requirement for GRT remained, causing confusion in the industry. This change conforms paragraph (c), which refers to not having sufficient experience, with paragraphs (a), (b), and (d), which all use 1,600 GRT as the standard to determine whether the applicant has sufficient experience.
In §§ 13.201(c)(3), 13.301(c)(3), 13.401(d), and 13.501(c)(3), this rule changes references to Table 1 to § 13.121(g) to the correct reference of Table 3 to § 13.121(e). In the 2013 STCW final rule, § 13.121 was revised, and what had been Table 13.121(g) (“Course topics” for firefighting) was renamed Table 3 to § 13.121(e). While in that same final rule, §§ 13.201(c)(3), 13.301(c)(3), 13.401(d), and 13.501(c)(3), all referenced “Table 1 to § 13.121(g),” when identifying an approved firefighting course, § 13.121(e)(1) and (3) make clear that “course curricula for firefighting courses must consist of the topics identified in Table 3 to § 13.121(e),” and that Table 1 to § 13.121(e) consists of course curricula topics for Tankship Familiarization.
In § 15.105(f), this rule corrects the cross-references defining the terms “fishing vessel” and “fish-tender vessel” from 46 U.S.C. 2101(11)(a) and (11)(c) to 46 U.S.C. 2101(12) and (14), respectively.
In § 15.812(e)(2), this rule corrects an error in the tables for the 2013 STCW final rule indicating that a Master, Mate, or Mate (Pilot) could serve as a pilot of a tank barge of greater than 10,000 GRT/GT, authorized to proceed beyond the Boundary Line or operate on the Great Lakes and on a route where a First Class Pilot's license or MMC officer endorsement is required. This is only true for tank barges of less than 10,000 GRT/GT; only individuals with an endorsement as First Class Pilot may pilot tank barges greater than 10,000 GRT/GT under such circumstances. The entry in Table 1 to § 15.812(e)(2) to the contrary is the result of a printing error; the Coast Guard's intent in this matter can be seen in current § 15.812(b)(3),
In § 31.10-16(e)(1), this rule updates the address for the National Cargo Bureau (NCB), as the organization relocated its New York offices.
In § 31.10-16(e)(2), this rule updates the address for the International Cargo Gear Bureau (ICGB), as the organization relocated its New York offices.
In § 71.30-10(a), this rule updates language referring to a Coast Guard inspector as “he.” Other regulations referencing Coast Guard inspectors have already been updated or were written with “he or she.”
In § 71.65-1(c), this rule updates the address for the ICGB, as the organization relocated its New York offices.
In §§ 91.25-50(a) and 91.27-15(a), this rule updates language referring to a Coast Guard inspector as “he.” Other regulations referencing Coast Guard inspectors have already been updated or were written with “he or she.”
In § 107.317(d), this rule updates the address for the ICGB, as the organization relocated its New York offices.
In § 126.100, this rule updates language referring to a Coast Guard inspector as “he.” Other regulations referencing Coast Guard inspectors have already been updated or were written with “he or she.”
In § 144.105, this rule removes an erroneous reference to the applicability of a nonexistent § 144.910 to the construction of new towing vessels, resulting from an editorial error in the 2016 Inspection of Towing Vessels final rule (81 FR 40101, June 20, 2016). In an earlier in-house draft of that rule, there were two sections addressing operating station visibility (§ 144.905 for existing vessels, and § 144.910 for new vessels). Since both sections had paragraphs that were nearly identical, the rule drafters merged the requirements into § 144.905 for the final rule, but overlooked the mention of § 144.910 in this section. There is no need to add a new reference to this section, since the requirements for new vessels are specifically identified in § 144.905(d) and (e).
In §§ 147.5 and 147.40, this rule changes references in the section titles from “Commandant (CG-OES)” to “Commandant (CG-ENG)” to match the contact information given in these sections.
In § 172.040(b), this rule updates the address for the NCB, as the organization relocated its New York offices.
In § 189.25-50(a), this rule updates language referring to a Coast Guard inspector as “he.” Other regulations referencing Coast Guard inspectors have already been updated or were written with “he or she.”
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on these statutes or Executive orders.
Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Two additional Executive orders were recently published to promote the goals of Executive Order 13563: Executive Order 13609 (Promoting International Regulatory Cooperation) and Executive Order 13610 (Identifying and Reducing Regulatory Burdens). Executive Order 13609 targets international regulatory cooperation to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. Executive Order 13610 aims to modernize the regulatory systems and to reduce unjustified regulatory burdens and costs on the public.
The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. A regulatory analysis follows.
This rule involves non-substantive technical amendments and internal agency practices and procedures; it will not impose any additional costs. The technical amendments in this rule fit into categories that involve (1) correcting inadvertent typographical errors in the CFR; (2) modifying existing language in the CFR by addition or subtraction to improve the readability or clarity of regulations; (3) removing irrelevant information, such as expired regulatory provisions or cancelled reference material, and replacing outdated regulatory information with current information where applicable; and (4) revising office contact information and mailing addresses. The Coast Guard does not expect that there will be any additional costs conferred on the public or the Federal Government because none of the technical and editorial changes included in this rule will change existing regulatory requirements. A summary of these amendments by category and by CFR title and section are presented below in table 1.
The unquantified benefits of the non-substantive technical amendments are increased accuracy of regulatory information by correcting erroneous information, improved readability and clarity of regulations by removing redundant or confusing language and by removing expired or cancelled provisions that are no longer relevant. In addition, the correction of technical items such as office mailing addresses and location coordinates will improve the accuracy of regulatory information and the ability to reference and contact the correct entities.
Under the Regulatory Flexibility Act, 5 U.S.C. 601-612, we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
This rule is not preceded by a notice of proposed rulemaking. The Regulatory Flexibility Act does not apply when notice and comment rulemaking is not required. Therefore, this rule is exempt from the requirements of the Regulatory Flexibility Act. This rule consists of technical, organizational, and conforming amendments and does not have any substantive effect on the regulated industry or small businesses.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, we offer to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3520.
A rule has implications for federalism under Executive Order 13132 (Federalism) if it has a substantial direct effect on States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under Executive Order 13132 and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
The Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531-1538, requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Although this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights).
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988 (Civil Justice Reform) to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045 (Protection of Children from Environmental Health Risks and Safety Risks). This rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule does not have tribal implications under Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
We have analyzed this rule under Executive Order 13211 (Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use). We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory act ion” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
The National Technology Transfer and Advancement Act, codified as a note to 15 U.S.C. 272, directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (for example, specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which
This rule is categorically excluded under paragraphs A3 and L54 of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. Paragraph A3 pertains to the promulgation of rules, issuance of rulings or interpretations, and the development and publication of policies, orders, directives, notices, procedures, manuals, advisory circulars, and other guidance documents of the following nature: (a) Those of a strictly administrative or procedural nature; (b) those that implement, without substantive change, statutory or regulatory requirements; (c) those that implement, without substantive change, procedures, manuals, and other guidance documents; and (d) those that interpret or amend an existing regulation without changing its environmental effect. Paragraph L54 pertains to regulations which are editorial or procedural. This final rule involves non-substantive technical, organizational, and conforming amendments to existing Coast Guard regulations.
Administrative practice and procedure, Authority delegations (Government agencies), Freedom of information, Penalties.
Harbors, Security measures, Vessels.
Navigation (water).
Administrative practice and procedure, Oil pollution, Penalties, Reporting and recordkeeping requirements, Water pollution control.
Administrative practice and procedure, Harbors, Hazardous materials transportation, Marine safety, Navigation (water), Personally identifiable information, Reporting and recordkeeping requirements, Seamen, Vessels, Waterways.
Marine safety, Reporting and recordkeeping requirements.
Administrative practice and procedure, Drug testing, Investigations, Marine safety, National Transportation Safety Board, Nuclear vessels, Radiation protection, Reporting and recordkeeping requirements, Safety, Transportation.
Administrative practice and procedure, Alcohol abuse, Drug abuse, Investigations, Seamen.
Law enforcement, Vessels.
Penalties, Reporting and recordkeeping requirements, Schools, Seamen.
Cargo vessels, Reporting and recordkeeping requirements, Seamen.
Reporting and recordkeeping requirements, Seamen, Vessels.
Cargo vessels, Marine safety, Reporting and recordkeeping requirements.
Reporting and recordkeeping requirements, Vessels.
Marine safety, Passenger vessels, Reporting and recordkeeping requirements.
Cargo vessels, Marine safety, Reporting and recordkeeping requirements.
Marine safety, Oil and gas exploration, Reporting and recordkeeping requirements, Vessels.
Cargo Vessels, Marine safety, Reporting and recordkeeping requirements.
Cargo vessels, Incorporation by reference, Marine safety, Oil and gas exploration, Passenger vessels, Reporting and recordkeeping requirements, Towing vessels.
Hazardous materials transportation, Labeling, Marine safety, Packaging and containers, Reporting and recordkeeping requirements.
Cargo vessels, Hazardous materials transportation, Marine safety.
Marine safety, Oceanographic research vessels, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 1, 6, 62, 151, 160, and 173 and 46 CFR parts 4, 5, 7, 11, 13, 15, 31, 67, 71, 91, 107, 126, 144, 147, 172, and 189 as follows:
14 U.S.C. 503; 14 U.S.C 501; 33 U.S.C. 1321(b)(6)(B); 46 U.S.C. 2103; DHS Delegation 00170.1, Revision No. 01.2.
40 Stat. 220, as amended; 50 U.S.C. 70051.
(d) Actions taken and decisions made under this part can be appealed through the procedures outlined in 33 CFR 160.7.
14 U.S.C. 544; 43 U.S.C. 1333; 46 U.S.C. 70031, 70041; DHS Delegation 00170.1, Revision No. 01.2.
33 U.S.C. 1902, 1903, 1908; 46 U.S.C. 6101; 46 U.S.C. 70034; Pub. L. 104-227, 110 Stat. 3034; sec. 623, Pub. L. 108-293, 118 Stat. 1063; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; DHS Delegation 00170.1, Revision No. 01.2, paragraph (II)(77).
46 U.S.C. 70001-70003, 70034, and Chapter 701; DHS Delegation 00170.1, Revision No. 01.2. Subpart C is also issued under the authority of 46 U.S.C. 3715 and 46 U.S.C. 70011.
31 U.S.C. 9701; 46 U.S.C. 2110, 6101, 12301, 12302; OMB Circular A-25; DHS Delegation 00170.1, Revision No. 01.2.
43 U.S.C. 1333; 46 U.S.C. 2103, 2303A, 2306, 6101, 6301, 6305, 70034; 50 U.S.C. 198; DHS Delegation 00170.1, Revision No. 01.2. Subpart 4.40 issued under 49 U.S.C. 1903(a)(1)(E).
46 U.S.C. 2103, 7101, 7301, 7701; DHS Delegation 00170.1, Revision No. 01.2.
14 U.S.C. 503; 33 U.S.C. 151; DHS Delegation 00170.1, Revision No. 01.2.
A line drawn from East Rockaway Inlet Breakwater Light (LLNR 31500) at 40°34′56.600″ N, 073°45′17.200″ W to 40°27′00″ N, 073°48′00″ W (former Ambrose Light position); thence to Highlands Light (LLNR 35025) (Private aid) (north tower) at 40°23′47.640″ N, 073°59′09.000″ W.
14 U.S.C. 503; 31 U.S.C. 9701; 46 U.S.C. 2101, 2103, and 2110; 46 U.S.C. chapter 71; 46 U.S.C. 7502, 7505, 7701, 8906, and 70105; E.O. 10173, 15 FR 7005, 3 CFR, 1949-1953 Comp., p.356; DHS Delegation 00170.1, Revision No. 01.2. Section 11.107 is also issued under the authority of 44 U.S.C. 3507.
46 U.S.C. 3703, 7317, 8105, 8703, 9102; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 2101, 2103, 3306, 3703, 8101, 8102, 8103, 8104, 8105, 8301, 8304, 8502, 8503, 8701, 8702, 8901, 8902, 8903, 8904, 8905(b), 8906 and 9102; sec. 617, Pub. L. 111-281, 124 Stat. 2905; and DHS Delegation 00170.1, Revision No. 01.2.
(e) * * *
(2) * * *
46 U.S.C. 2103, 3205, 3306, 3307, 3703, 70034; 46 U.S.C. Chapter 701; 49 U.S.C. 5103, 5106; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; DHS Delegation 00170.1, Revision No. 01.2. Section 31.10-21 is also issued under the authority of sec. 4109, Pub. L. 101-380, 104 Stat. 515.
14 U.S.C. 664; 31 U.S.C. 9701; 42 U.S.C. 9118; 46 U.S.C. 2103, 2104, 2107, 12102, 12103, 12104, 12105, 12106, 12113, 12133, 12139; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 2113, 3205, 3306, 3307, 70034; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 3205, 3306, 3307, 70034; 46 U.S.C. Chapter 701; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; DHS Delegation 00170.1, Revision No. 01.2.
43 U.S.C. 1333; 46 U.S.C. 3306, 3307; 46 U.S.C. 3316; DHS Delegation 00170.1, Revision No. 01.2. Section 107.05 is also issued under the authority of 44 U.S.C. 3507.
46 U.S.C. 3205, 3306, 3307, 70034; 46 U.S.C. Chapter 701; sec. 617, Pub. L. 111-281, 124 Stat. 2905; E.O. 11735, 38 FR 21243, 3 CFR 1971-1975 Comp., p. 793; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 3103, 3301, 3306, 3308, 3316, 8104, 8904; 33 CFR 1.05; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 3306; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 3306, 3703, 5115; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; DHS Delegation 00170.1, Revision No. 01.2.
46 U.S.C. 2113, 3306, 3307, 70034; E.O. 12234, 45 FR 58801, 3 CFR, 1980 Comp., p. 277; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p. 351; DHS Delegation 00170.1, Revision No. 01.2.
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is providing public notice of inflationary adjustments to the maximum civil monetary penalties assessed or enforced by VA, as implemented by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, for calendar year 2022. VA may impose civil monetary penalties for false loan guaranty certifications. Also, VA may impose civil monetary penalties for fraudulent claims or written statements made in connection with VA programs generally. The Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015, sets forth a formula that increases the maximum statutory amounts for civil monetary penalties and directs VA to give public notice of the new maximum amounts by regulation.
Stephanie Li, Chief, Regulations Team, Loan Guaranty Service, Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 632-8862. (This is not a toll-free number.)
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act) (Pub. L. 114-74, sec. 701, 129 Stat. 599), which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410, 104 Stat. 890), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act was codified in a note following 28 U.S.C. 2461. The 2015 Act requires agencies to publish annual adjustments for inflation, based on the percentage change between the Consumer Price Index (defined in the Act as the Consumer Price Index for all-urban consumers (CPI-U) published by the Department of Labor) for the month of October preceding the date of the adjustment and the prior year's October CPI-U. 28 U.S.C. 2461 note, secs. 4(a) and (b) and 5(b)(1). This rule implements the 2022 calendar year inflation adjustment amounts.
Under 38 U.S.C. 3710(g)(4)(B), VA is authorized to levy civil monetary penalties against private lenders that originate VA-guaranteed loans if a lender falsely certifies that they have complied with certain credit information and loan processing standards, as set forth by chapter 37, title 38 U.S.C. and part 36, title 38 CFR. Under section 3710(g)(4)(B), any lender who knowingly and willfully makes such a false certification shall be liable to the United States Government for a civil penalty equal to two times the amount of the Secretary's loss on the loan involved or to another appropriate amount, not to exceed $10,000, whichever is greater. VA implemented the penalty amount in 38 CFR 36.4340(k)(1)(i) and (k)(3). On December 15, 2021, the Office of Management and Budget (OMB) issued Circular M-22-07. This circular reflects that the October 2020 CPI-U was 260.388 and the October 2021 CPI-U was 276.589, resulting in an inflation adjustment multiplier of 1.06222. Accordingly, the calendar year 2022 inflation revision imposes an adjustment from $23,607 to $25,076.
Under 31 U.S.C. 3802, VA can impose monetary penalties against any person who makes, presents, or submits a claim or written statement to VA that the person knows or has reason to know is false, fictitious, or fraudulent, or who engages in other covered conduct. The statute permits, in addition to any other remedy that may be prescribed by law, a civil penalty of not more than $5,000 for each claim. 31 U.S.C. 3802(a)(1) and (2). VA implemented the penalty amount in 38 CFR 42.3(a)(1) and (b)(1). As previously noted, OMB Circular M-22-07 reflects an inflation adjustment multiplier of 1.06222. Therefore, the calendar year 2022 inflation revision imposes an adjustment from $11,803 to $12,537.
Accordingly, VA is revising 38 CFR 36.4340(k)(1)(i) and (3) and 38 CFR 42.3(a)(1) and (b)(1) to reflect the 2022 inflationary adjustments for civil monetary penalties assessed or enforced by VA.
The Secretary of Veterans Affairs finds that there is good cause under 5 U.S.C. 553(b)(B) and (d)(3) to dispense with the opportunity for prior notice and public comment and to publish this rule with an immediate effective date. The 2015 Act requires agencies to make annual adjustments for inflation to the allowed amounts of civil monetary penalties “notwithstanding section 553 of title 5, United States Code.” 28 U.S.C. 2461 note, sec. 4(a) and (b). The penalty adjustments, and the methodology used to determine the adjustments, are set by the terms of the 2015 Act. VA has no discretion to make changes in those areas. Therefore, an opportunity for prior notice and public comment and a delayed effective date are unnecessary.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory
The Regulatory Flexibility Act, 5 U.S.C. 601
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This final rule will have no such effect on State, local, and tribal governments, or on the private sector.
This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The Assistance Listing number and title for the program affected by this document is 64.114, Veterans Housing Guaranteed and Insured Loans.
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (known as the Congressional Review Act) (5 U.S.C. 801
Condominiums, Housing, Individuals with disabilities, Loan programs-housing and community development, Loan programs-veterans, Manufactured homes, Mortgage insurance, Reporting and recordkeeping requirements, Veterans.
Administrative practice and procedure, Claims, Fraud, Penalties.
Denis McDonough, Secretary of Veterans Affairs, approved this document on January 14, 2022, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
For the reasons stated in the preamble, the Department of Veterans Affairs amends 38 CFR parts 36 and 42 as set forth below:
38 U.S.C. 501 and 3720.
Pub. L. 99-509, secs. 6101-6104, 100 Stat. 1874, codified at 31 U.S.C. 3801-3812.
Federal Communications Commission.
Final rule.
On September 20, 2021, the Media Bureau, Video Division (Bureau) issued a
Effective January 21, 2022.
Joyce Bernstein, Media Bureau, at (202) 418-1647 or
The proposed rule was published at 86 FR 54144 on September 30, 2021. The Petitioner filed comments in support of the petition, as required by the Commission's rules, reaffirming its commitment to apply for channel *4 and if authorized, to build a station promptly. No other comments were filed. We believe the public interest would be served by allotting channel *4 at Fort Bragg, California. Fort Bragg (population 7,179) clearly qualifies for community of license status for allotment purposes. In addition, the proposal would result in a second local service to Fort Bragg under the Commission's third allotment priority. Moreover, the allotment is consistent with the minimum geographic spacing requirements for new DTV allotments in
This is a synopsis of the Commission's
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will send a copy of this
Television.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.
(j) * * *
Federal Communications Commission.
Final rule.
On July 28, 2021, the Media Bureau, Video Division (Bureau) issued a
Effective January 21, 2022.
Joyce Bernstein, Media Bureau, at (202) 418-1647 or
The proposed rule was published at 86 FR 41916 on August 4, 2021. The Petitioner filed comments in support of the petition reaffirming its commitment to apply for channel 24. Gray Television, LLC, which acquired the station, also filed comments in support of the petition and stating its commitment to apply for channel 24. In support of its channel substitution request, the Petitioner states that the Commission has recognized that VHF channels have certain characteristics that pose challenges for their use in providing digital television service, and that KVVU-TV has received numerous complaints of poor or no reception from viewers within its noise limited contour. While the channel 24 noise limited contour will not fully encompass the existing channel 9 contour, only 152 persons would lose service from KVVU, and no viewers would lose access to their first or second over-the-air television service. While 152 persons are predicted to lose service from KVVU, the Commission considers such a loss to be
This is a synopsis of the Commission's
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will send a copy of this
Television.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 155, 301, 303, 307, 309, 310, 334, 336, 339.
(j) * * *
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notification of a webinar and availability of preliminary technical support document.
The U.S. Department of Energy (“DOE” or “the Department”) will hold a webinar to discuss and receive comments on the preliminary analysis it has conducted for purposes of evaluating energy conservation standards for miscellaneous refrigeration products (“MREFs”). The meeting will cover the analytical framework, models, and tools that DOE is using to evaluate potential standards for these products; the results of preliminary analyses performed by DOE; the potential energy conservation standard levels derived from these analyses that DOE could consider for this product should it determine that proposed amendments are necessary; and any other issues relevant to the evaluation of energy conservation standards for MREFs. In addition, DOE encourages written comments on these subjects. To inform interested parties and to facilitate this process, DOE has prepared an agenda, a preliminary technical support document (“TSD”), and briefing materials, which are available on the DOE website at:
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
1.
2.
No telefacsimiles (“faxes”) will be accepted. For detailed instructions on submitting comments and additional information on this process, see section IV of this document.
Although DOE has routinely accepted public comment submissions through a variety of mechanisms, including postal mail and hand delivery/courier, the Department has found it necessary to make temporary modifications to the comment submission process in light of the ongoing corona virus 2019 (“COVID-19”) pandemic. DOE is currently suspending receipt of public comments via postal mail and hand delivery/courier. If a commenter finds that this change poses an undue hardship, please contact Appliance Standards Program staff at (202) 586-1445 to discuss the need for alternative arrangements. Once the COVID-19 pandemic health emergency is resolved, DOE anticipates resuming all of its regular options for public comment submission, including postal mail and hand delivery/courier.
The docket web page can be found at
Dr. Stephanie Johnson, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies, EE-2J, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-1943. Email:
Mr. Michael Kido, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 586-8145. Email:
For further information on how to submit a comment, review other public comments and the docket, contact the Appliance and Equipment Standards Program staff at (202) 287-1445 or by email:
The Energy Policy and Conservation Act, as amended (“EPCA”),
EPCA further provides that, not later than 6 years after the issuance of any final rule establishing or amending a standard, DOE must publish either a notification of determination that standards for the product do not need to be amended, or a notice of proposed rulemaking (“NOPR”) including new proposed energy conservation standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m)(1)) Not later than three years after issuance of a final determination not to amend standards, DOE must publish either a notice of determination that standards for the product do not need to be amended, or a NOPR including new proposed energy conservation standards (proceeding to a final rule, as appropriate). (42 U.S.C. 6295(m)(3)(B))
Under EPCA, any new or amended energy conservation standard must be designed to achieve the maximum improvement in energy efficiency that DOE determines is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, the new or amended standard must result in a significant conservation of energy. (42 U.S.C. 6295(o)(3)(B))
DOE is publishing this Preliminary Analysis to collect data and information to inform its decision consistent with its obligations under EPCA.
DOE must follow specific statutory criteria for prescribing new or amended standards for covered products, including MREFs. As noted, EPCA requires that any new or amended energy conservation standard prescribed by the Secretary of Energy (“Secretary”) be designed to achieve the maximum improvement in energy efficiency (or water efficiency for certain products specified by EPCA) that is technologically feasible and economically justified. (42 U.S.C. 6295(o)(2)(A)) Furthermore, DOE may not adopt any standard that would not result in the significant conservation of energy. (42 U.S.C. 6295(o)(3)) The Secretary may not prescribe an amended or new standard that will not result in significant conservation of energy, or is not technologically feasible or economically justified. (42 U.S.C. 6295(o)(3))
To adopt any new or amended standards for a covered product, DOE must determine that such action would result in significant energy savings. (42 U.S.C. 6295(o)(3)(B)) Although the term “significant” is not defined in the EPCA, the U.S. Court of Appeals, for the District of Columbia Circuit in
The significance of energy savings offered by a new or amended energy conservation standard cannot be determined without knowledge of the specific circumstances surrounding a given rulemaking.
Accordingly, DOE evaluates the significance of energy savings on a case-by-case basis. DOE estimates a combined total of 0.45 quads of FFC energy savings at the max-tech efficiency levels for MREFs. This represents 44.4 percent energy savings relative to the no-new-standards case energy consumption for MREFs. DOE has initially determined the energy savings for the candidate standard levels considered in this preliminary analysis are “significant” within the meaning of 42 U.S.C. 6295(o)(3)(B).
To determine whether a standard is economically justified, EPCA requires that DOE determine whether the benefits of the standard exceed its burdens by considering, to the greatest extent practicable, the following seven factors:
(1) The economic impact of the standard on the manufacturers and consumers of the products subject to the standard;
(2) The savings in operating costs throughout the estimated average life of the covered products in the type (or class) compared to any increase in the price, initial charges, or maintenance expenses for the covered products that are likely to result from the standard;
(3) The total projected amount of energy (or as applicable, water) savings likely to result directly from the standard;
(4) Any lessening of the utility or the performance of the products likely to result from the standard;
(5) The impact of any lessening of competition, as determined in writing by the Attorney General, that is likely to result from the standard;
(6) The need for national energy and water conservation; and
(7) Other factors the Secretary of Energy (Secretary) considers relevant.(42 U.S.C. 6295(o)(2)(B)(i)(I)-(VII))
DOE fulfills these and other applicable requirements by conducting a series of analyses throughout the rulemaking process. Table I.1 shows the individual analyses that are performed
Further, EPCA establishes a rebuttable presumption that a standard is economically justified if the Secretary finds that the additional cost to the consumer of purchasing a product complying with an energy conservation standard level will be less than three times the value of the energy savings during the first year that the consumer will receive as a result of the standard, as calculated under the applicable test procedure. (42 U.S.C. 6295(o)(2)(B)(iii))
EPCA also contains what is known as an “anti-backsliding” provision, which prevents the Secretary from prescribing any amended standard that either increases the maximum allowable energy use or decreases the minimum required energy efficiency of a covered product. (42 U.S.C. 6295(o)(1)) Also, the Secretary may not prescribe an amended or new standard if interested persons have established by a preponderance of the evidence that the standard is likely to result in the unavailability in the United States in any covered product type (or class) of performance characteristics (including reliability), features, sizes, capacities, and volumes that are substantially the same as those generally available in the United States. (42 U.S.C. 6295(o)(4))
Additionally, EPCA specifies requirements when promulgating an energy conservation standard for a covered product that has two or more subcategories. DOE must specify a different standard level for a type or class of product that has the same function or intended use, if DOE determines that products within such group: (A) Consume a different kind of energy from that consumed by other covered products within such type (or class); or (B) have a capacity or other performance-related feature which other products within such type (or class) do not have and such feature justifies a higher or lower standard. (42 U.S.C. 6295(q)(1)) In determining whether a performance-related feature justifies a different standard for a group of products, DOE must consider such factors as the utility to the consumer of the feature and other factors DOE deems appropriate.
Finally, pursuant to the amendments contained in the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, any final rule for new or amended energy conservation standards promulgated after July 1, 2010, is required to address standby mode and off mode energy use. (42 U.S.C. 6295(gg)(3)) Specifically, when DOE adopts a standard for a covered product after that date, it must, if justified by the criteria for adoption of standards under EPCA (42 U.S.C. 6295(o)), incorporate standby mode and off mode energy use into a single standard, or, if that is not feasible, adopt a separate standard for such energy use for that product. (42 U.S.C. 6295(gg)(3)(A)-(B)) DOE's current test procedure for MREFs measures the energy use of these products during extended time periods that include periods when the compressor and other key components are cycled off. All of the energy these products use during the “off cycles” is already included in the measurements. By measuring the energy use during “off cycles,” the current test procedure already addresses EPCA's requirement to include standby mode and off mode energy consumption in the overall energy descriptor for MREFs. See 86 FR 56790 (October 12, 2021) (final rule amending the test procedures for consumer refrigeration products). As a result, DOE's current energy conservation standards and any amended energy conservation standards account for such energy use.
Before proposing a standard, DOE typically seeks public input on the analytical framework, models, and tools that DOE intends to use to evaluate standards for the product at issue and the results of the preliminary analyses DOE performed for the product.
DOE is examining whether to amend the current standards pursuant to its
In accordance with section 3(a) of 10 CFR part 430, subpart C, appendix A (“appendix A”), DOE notes that it is deviating from the provision in appendix A regarding the pre-NOPR stages for an energy conservation standards rulemaking. (
Section 6(d)(2) of appendix A specifies that the length of the public comment period for pre-NOPR rulemaking documents will vary depending upon the circumstances of the particular rulemaking, but will not be less than 75 calendar days. For this preliminary analysis, DOE has opted to instead provide a 60-day comment period. As stated, DOE requested comment in the December 2020 Early Assessment Review RFI on the analysis conducted in support of the October 2016 Direct Final Rule and provided stakeholders a 75-day comment period. For this preliminary analysis, DOE has relied on many of the same analytical assumptions and approaches as used in the previous rulemaking and has determined that a 60-day comment period in conjunction with the prior 75-day comment period provides sufficient time for interested parties to review the preliminary analysis and develop comments.
As noted, DOE added MREFs as covered products through its July 2016 Final Coverage Determination. 81 FR 46768. In that determination, DOE noted that MREFs, on average, consume more than 150 kilowatt hours per year (“kWh/yr”) and that the aggregate annual national energy use of these products exceeds 4.2 terawatt hours (“TWh”). 81 FR 46768, 46775. In addition to establishing coverage, the July 2016 Final Coverage Determination established definitions for “miscellaneous refrigeration products,” “coolers,” and “combination cooler refrigeration products” in 10 CFR 430.2. 81 FR 46768, 46791-46792.
In the October 2016 Direct Final Rule, DOE adopted energy conservation standards for MREFs consistent with the recommendations from a negotiated rulemaking working group established under the Appliance Standards and Rulemaking Federal Advisory Committee. 81 FR 75194. Concurrent with the October 2016 Direct Final Rule, DOE published a NOPR in which it proposed and requested comments on the standards set forth in the direct final rule. 81 FR 74950. On May 26, 2017, DOE published a notice in the
These current standards for MREFs are set forth in DOE's regulations at 10 CFR 430.32(aa)(1)-(2) and are repeated solely for reference in Table II.1 to aid the reader.
In the December 2020 Early Assessment Review RFI, DOE published a notice that it was initiating an early assessment review to determine whether any new or amended standards would satisfy the relevant requirements of EPCA for a new or amended energy conservation standard for MREFs and a request for information. 85 FR 78964.
Comments received to date as part of the current process have helped DOE identify and resolve issues related to the preliminary analyses. Chapter 2 of the preliminary TSD summarizes and addresses the comments received.
For the products covered in this preliminary analysis, DOE conducted in-depth technical analyses in the following areas: (1) Engineering; (2) markups to determine product price; (3) energy use; (4) life cycle cost (“LCC”) and payback period (“PBP”); and (5) national impacts. The preliminary TSD that presents the methodology and results of each of these analyses is available at
DOE also conducted, and has included in the preliminary TSD, several other analyses that support the major analyses or are preliminary analyses that will be expanded if DOE determines that a NOPR is warranted to propose amended energy conservation standards. These analyses include: (1) The market and technology assessment; (2) the screening analysis, which contributes to the engineering analysis; and (3) the shipments analysis, which contributes to the LCC and PBP analysis and the national impact analysis (“NIA”). In addition to these analyses, DOE has begun preliminary work on the manufacturer impact analysis and has identified the methods to be used for the consumer subgroup analysis, the emissions analysis, the employment impact analysis, the regulatory impact analysis, and the utility impact analysis. DOE will expand on these analyses in a NOPR, should one be issued.
DOE develops information in the market and technology assessment that provides an overall picture of the market for the products concerned, including general characteristics of the products, the industry structure, manufacturers, market characteristics, and technologies used in the products. This activity includes both quantitative and qualitative assessments, based primarily on publicly available information. The subjects addressed in the market and technology assessment include: (1) A determination of the scope of the rulemaking and product classes, (2) manufacturers and industry structure, (3) existing efficiency programs, (4) shipments information, (5) market and industry trends, and (6) technologies or design options that could improve the energy efficiency of the product.
See chapter 3 of the preliminary TSD for further discussion of the market and technology assessment.
DOE uses the following five screening criteria to determine which technology options are suitable for further consideration in an energy conservation standards rulemaking:
(1)
(2)
(3)
(4)
(5)
10 CFR part 430, subpart C, appendix A, sections 6(c)(3) and 7(b).
If DOE determines that a technology, or a combination of technologies, fails to meet one or more of the listed five criteria, it will be excluded from further consideration in the engineering analysis.
See chapter 4 of the preliminary TSD for further discussion of the screening analysis.
The purpose of the engineering analysis is to establish the relationship between the efficiency and cost of MREFs. There are two elements to consider in the engineering analysis; the selection of efficiency levels to analyze (
DOE converts the MPC to the manufacturer selling price (“MSP”) by applying a manufacturer markup. The MSP is the price the manufacturer charges its first customer, when selling into the product distribution channels. The manufacturer markup accounts for manufacturer non-production costs and profit margin. DOE developed the manufacturer markup by examining publicly available financial information for manufacturers of the covered product.
See Chapter 5 of the preliminary TSD for additional detail on the engineering analysis.
The markups analysis develops appropriate markups (
DOE develops baseline and incremental markups for each actor in the distribution chain (after the product leaves the manufacturer). Baseline markups are applied to the price of products with baseline efficiency, while incremental markups are applied to the difference in price between baseline and higher-efficiency models (the incremental cost increase). The
Chapter 6 of the preliminary TSD provides details on DOE's development of markups for MREFs. Chapter 12 of the preliminary TSD provides additional detail on the manufacturer markup.
The purpose of the energy use analysis is to determine the annual energy consumption of MREFs at different efficiencies in representative U.S. single-family homes, and multi-family residences, and to assess the energy savings potential of increased MREF efficiency. The energy use analysis estimates the range of energy use of MREFs in the field (
Chapter 7 of the preliminary TSD addresses the energy use analysis.
The effect of new or amended energy conservation standards on individual consumers usually involves a reduction in operating cost and an increase in purchase cost. DOE used the following two metrics to measure consumer impacts:
• The LCC is the total consumer expense of an appliance or product over the life of that product, consisting of total installed cost (manufacturer selling price, distribution chain markups, sales tax, and installation costs) plus operating costs (expenses for energy use, maintenance, and repair). To compute the operating costs, DOE discounts future operating costs to the time of purchase and sums them over the lifetime of the product.
• The PBP is the estimated amount of time (in years) it takes consumers to recover the increased purchase cost (including installation) of a more-efficient product through lower operating costs. DOE calculates the PBP by dividing the change in purchase cost at higher efficiency levels by the change in annual operating cost for the year that amended or new standards are assumed to take effect.
Chapter 8 of the preliminary TSD addresses the LCC and PBP analyses.
The NIA estimates the national energy savings (“NES”) and the net present value (“NPV”) of total consumer costs and savings expected to result from amended standards at specific efficiency levels (referred to as candidate standard levels).
DOE evaluates the impacts of new or amended standards by comparing a case without such standards with standards-case projections (“no-new-standards case”). The no-new-standards case characterizes energy use and consumer costs for each product class in the absence of new or amended energy conservation standards. For this projection, DOE considers historical trends in efficiency and various forces that are likely to affect the mix of efficiencies over time. DOE compares the no-new-standards case with projections characterizing the market for each product class if DOE adopted new or amended standards at specific energy efficiency levels for that class. For each efficiency level, DOE considers how a given standard would likely affect the market shares of those products with efficiencies greater than the standard.
DOE uses a spreadsheet model to calculate the energy savings and the national consumer costs and savings from each efficiency level. Interested parties can review DOE's analyses by changing various input quantities within the spreadsheet. The NIA spreadsheet model uses typical values (as opposed to probability distributions) as inputs. Critical inputs to this analysis include shipments projections, estimated product lifetimes, product installed costs and operating costs, product annual energy consumption, the base case efficiency projection, and discount rates.
DOE estimates a combined total of 0.16 quads of site energy savings at the max-tech efficiency levels for MREFs. This represents 44.4 percent energy savings relative to the no-new-standards case energy consumption for MREFs.
Chapter 10 of the preliminary TSD addresses the NIA.
DOE invites public participation in this process through participation in the webinar and submission of written comments and information. After the webinar and the closing of the comment period, DOE will consider all timely-submitted comments and additional information obtained from interested parties, as well as information obtained through further analyses. Following such consideration, the Department will publish either a determination that the standards for MREFs need not be amended or a NOPR proposing to amend those standards. The NOPR, should one be issued, would include proposed energy conservation standards for the products covered by that rulemaking, and members of the public would be given an opportunity to submit written and oral comments on the proposed standards.
The time and date for the webinar meeting are listed in the
Any person who has an interest in the topics addressed in this document, or who is representative of a group or class of persons that has an interest in these issues, may request an opportunity to make an oral presentation at the webinar. Such persons may submit such request to
DOE will designate a DOE official to preside at the webinar and may also use a professional facilitator to aid discussion. The webinar will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in accordance with section 336 of EPCA (42 U.S.C. 6306). A court reporter will be present to record the proceedings and prepare a transcript. DOE reserves the right to schedule the order of presentations and to establish the procedures governing the conduct of the webinar. There shall not be discussion of proprietary information, costs or prices, market share, or other commercial matters regulated by U.S. anti-trust laws. After the webinar and until the end of the comment period, interested parties may submit further comments on the proceedings and any aspect of the rulemaking.
The webinar will be conducted in an informal, conference style. DOE will present summaries of comments received before the webinar, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will permit, as time permits, other participants to comment briefly on any general statements.
At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this rulemaking. The official conducting the webinar will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the webinar.
A transcript of the webinar will be included in the docket, which can be viewed as described in the
DOE invites all interested parties, regardless of whether they participate in the public meeting, to submit in writing by March 22, 2022, comments and information on matters addressed in this notification and on other matters relevant to DOE's consideration of amended energy conservations standards for MREFs. Interested parties may submit comments, data, and other information using any of the methods described in the
However, your contact information will be publicly viewable if you include it in the comment itself or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. If this instruction is followed, persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
Do not submit to
DOE processes submissions made through
Include contact information each time you submit comments, data, documents, and other information to DOE. No faxes will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, or text (ASCII) file format. Provide documents that are not secured, that are written in English, and that are free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
The Secretary of Energy has approved publication of this notification of a webinar and availability of preliminary technical support document.
This document of the Department of Energy was signed on January 12, 2022, by Kelly J. Speakes-Backman, Principal Deputy Assistant Secretary for Energy Efficiency and Renewable Energy, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Viking Air Limited (Viking) (type certificate previously held by Bombardier Inc. and de Havilland, Inc.) Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as cracks and corrosion damage to the aileron internal structure. This proposed AD would require visually inspecting the entire aileron internal structure, correcting any damage found, and reporting the inspection results to Viking. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by March 7, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Viking Air Ltd., 1959 de Havilland Way, Sidney British Columbia, Canada V8L 5V5; phone: (800) 663-8444; email:
You may examine the AD docket at
Deep Gaurav, Aviation Safety Engineer, New York ACO Branch, FAA, 1515 Stewart Avenue, Westbury, NY 11590; phone: (516) 228-7300; fax: (516) 794-5331; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Deep Gaurav, Aviation Safety Engineer, New York ACO Branch, FAA, 1515 Stewart Avenue, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
Transport Canada, which is the aviation authority for Canada, has issued Transport Canada AD CF-2020-05, dated March 13, 2020 (referred to after this as “the MCAI”), to address the unsafe condition on Viking Model DHC-6 series 1, DHC-6 series 100, DHC-6 series 110, DHC-6 series 200, DHC-6 series 210, DHC-6 series 300, DHC-6 series 310, DHC-6 series 320, and DHC-6 series 400 airplanes. The MCAI states:
Viking Air Ltd. (Viking) received reports of cracks and corrosion damage to the aileron internal structure. During a repair of an in-service aeroplane, an aileron hinge support rib was found cracked at the lower flange along the bend radius near the hinge fitting attachment at wing station 247.29. Preliminary investigation by Viking
The current inspection requirements of the affected aeroplanes do not include a direct inspection of the aileron internal structure. Cracks or other damage to the aileron ribs or to the aileron spar flanges are not detectable from the aileron exterior surfaces. Undetected cracks or other damage to the aileron internal structure could lead to progressive looseness of the aileron at the hinge support rib push-pull rod attachment and subsequent flutter condition and degraded or loss of aileron control.
To detect and correct any cracking or other damage to the aileron internal structure, this [Transport Canada] AD mandates a one-time Special Detailed Inspection (SDI) of all aileron internal structure, including front and rear spars, all aileron ribs and upper and lower skins for cracks, corrosion or other damage, and rectification, as required, of the damaged parts.
This [Transport Canada] AD also mandates reporting of all inspection results to Viking. The reporting of the inspection results is necessary to assess the overall aileron internal structural condition on in-service aeroplanes and to determine additional corrective action based on the results of the inspections.
Viking has published Service Bulletin (SB) V6/0066 Revision A, dated 9 December 2019, (referred to as “the SB” in this AD) providing accomplishment instructions for the inspection, rectification of the damaged parts, and reporting requirements.
You may examine the MCAI in the AD docket at
The FAA reviewed Viking DHC-6 Twin Otter Service Bulletin V6/0066, Revision A, dated December 9, 2019. The service information specifies procedures for visually inspecting the entire aileron internal structure, including front and rear spars, all aileron ribs, and upper and lower skins; repairing or replacing any damaged part; and reporting inspection results to Viking Air Limited technical support. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA reviewed Viking DHC-6 Twin Otter Service Bulletin V6/0066, Revision NC, dated August 29, 2019. The service information specifies procedures for visually inspecting the aileron ribs, including ribs and both sides of the hinge arm; repairing or replacing any damaged part; and reporting inspection results to Viking Air Limited technical support.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI and service information referenced above. The FAA is issuing this NPRM after determining the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information described previously.
The FAA considers that this proposed AD would be an interim action. The inspection reports will provide the FAA and Viking Air Limited additional data for determining the damage present in the fleet. After analyzing the data, the FAA may take further rulemaking action.
The MCAI applies to Viking Air Limited Model DHC-6 series 110, DHC-6 series 210, DHC-6 series 310, and DHC-6 series 320, and this proposed AD would not because these models do not have an FAA type certificate. Transport Canada Model DHC-6 series 1, DHC-6 series 100, DHC-6 series 200, DHC-6 series 300, and DHC-6 series 400 airplanes correspond to FAA Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes, respectively.
The FAA estimates that this AD, if adopted as proposed, would affect 33 airplanes of U.S. registry. The FAA also estimates that it would take about 3 work-hours per airplane to comply with the inspection and 1 hour to comply with the reporting requirement of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, the FAA estimates the cost of the proposed AD on U.S. operators would be $11,220 or $340 per airplane.
In addition, the FAA estimates that any necessary follow-on actions to replace an aileron would take 6 work-hours and require parts costing $52,243, for a cost of $52,753 per airplane. The FAA has no way of determining the number of airplanes that may need these actions.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid OMB Control Number. The OMB Control Number for this information collection is 2120-0056. Public reporting for this collection of information is estimated to take approximately 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. All responses to this collection of information are mandatory. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Information Collection Clearance Officer, Federal Aviation Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Will not affect intrastate aviation in Alaska, and
(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by March 7, 2022.
None.
This AD applies to Viking Air Limited (type certificate previously held by Bombardier Inc. and de Havilland, Inc.) Model DHC-6-1, DHC-6-100, DHC-6-200, DHC-6-300, and DHC-6-400 airplanes, all serial numbers, certificated in any category.
Joint Aircraft System Component (JASC) Code 5700, Wing Structure.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI identifies the unsafe condition as cracks and corrosion damage to the aileron internal structure. The FAA is issuing this AD to detect and correct cracks and other damage to the aileron internal structure. The unsafe condition, if not addressed, could result in progressive looseness of the aileron at the hinge support rib push-pull rod attachment, flutter condition, and degraded or loss of aileron control, which could lead to loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
At the compliance time specified in paragraph (g)(1) or (2) of this AD, inspect the left-hand (LH) and right-hand (RH) aileron internal structures for cracks, corrosion, and other damage and take any necessary corrective actions in accordance with the Accomplishment Instructions, steps II.A. through II.A.3. of Viking DHC-6 Twin Otter Service Bulletin V6/0066, Revision A, dated December 9, 2019 (Viking SB V6/0066, Revision A).
(1) For each LH or RH aileron that has accumulated 16,000 or more hours time-in-service (TIS), 32,000 or more flight cycles (FC), or 10 or more years since first installation on an airplane, whichever occurs first: Within 6 months after the effective date of this AD.
(2) For each LH or RH aileron that has accumulated less than 16,000 hours TIS, less than 32,000 FC, and less than 10 years since first installation on an airplane: Within 6 months after accumulating 16,000 hours TIS, 32,000 FC, or 10 years, whichever occurs first.
Within 30 days after the inspection required by paragraph (g)(1) or (2) of this AD or within 30 days after the effective date of this AD, whichever occurs later, report to Viking the information requested on the Inspection Reply Form, page 7, of Viking SB V6/0066, Revision A.
You may take credit for the actions required by paragraphs (g)(1) and (2) of this AD if you performed those actions before the effective date of this AD using Viking DHC-6 Twin Otter Service Bulletin V6/0066, Revision NC, dated August 29, 2019.
(1) The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (k)(1) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Deep Gaurav, Aviation Safety Engineer, New York ACO Branch, FAA, 1515 Stewart Avenue, Westbury, NY 11590; phone: (516) 228-7300; fax: (516) 794-5331; email:
(2) Refer to Transport Canada AD CF-2020-05, dated March 13, 2020, for more information. You may examine the Transport Canada AD in the AD docket at
(3) For service information identified in this AD, contact Viking Air Ltd., 1959 de Havilland Way, Sidney British Columbia, Canada V8L 5V5; phone: (800) 663-8444; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Viking Air Limited (type certificate previously held by Bombardier Inc. and de Havilland, Inc.) Model DHC-6-400 airplanes. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as corrosion of the
The FAA must receive comments on this proposed AD by March 7, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Viking Air Limited Technical Support, 1959 de Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; phone: (North America) (800) 663-8444; fax: (250) 656-0673; email:
You may examine the AD docket at
Joseph Catanzaro, Aviation Safety Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7366; fax: (516) 794-5531; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Joseph Catanzaro, Aviation Safety Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
Transport Canada, which is the aviation authority for Canada, has issued Canadian AD CF-2018-07, dated February 23, 2018 (referred to after this as “the MCAI”), to correct an unsafe condition on certain serial-numbered Viking Air Limited Model DHC-6-400 airplanes. The MCAI states:
There have been reports of corrosion affecting components of the fuel system that are located in the fuel gallery because of inadequate corrosion protection. This condition affects only aeroplanes operating on floats.
The effects of corrosion-related damage to fuel system components have included fuel leaks, electrical arcing, loss of fuel boost pump function and erroneous fuel quantity readings. Inaccurate fuel quantity indication and loss of fuel boost pump function can lead to fuel starvation followed by loss of engine power. Electrical arcing in the fuel gallery and loss of electrical bonding between fuel system components increases the risk of fire.
The MCAI requires repetitively inspecting the fuel gallery for corrosion, rectifying any deficiencies, and accomplishing modifications to the fuel gallery system. You may examine the MCAI in the AD docket at
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, it has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this NPRM after determining the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed Viking DHC-6 Twin Otter Service Bulletin V6/0044, Revision `B', dated September 13, 2021. The service information specifies incorporating multiple design improvement modifications in the fuel gallery.
The FAA also reviewed Temporary Revision No. 241, dated July 27, 2021, to the Viking DHC-6 Inspection Requirements Manual, PSM 1-6-7. Items 15.(1) and 15.(2) of this service information specifies rinsing and inspecting the entire fuel gallery for corrosion; removing corrosion; reapplying any protective finishes; and removing and replacing any damaged components. The temporary revision updates the fuel gallery inspection to include airplanes with a new fuel probe (Modification (MOD) 6/2395).
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
The FAA reviewed the following technical bulletins related to this NPRM, which contain instructions for
• Viking DHC-6 Twin Otter Technical Bulletin TBV6/00034, Revision NC, dated October 16, 2013 (MOD 6/2267);
• Viking DHC-6 Twin Otter Technical Bulletin TBV6/00084, Revision A, dated May 26, 2017 (MOD 6/2299);
• Viking DHC-6 Twin Otter Technical Bulletin V6/00099, Revision NC, dated December 23, 2016 (MOD 6/2389);
• Viking DHC-6 Twin Otter Technical Bulletin. TBV6/00094, Revision NC, dated November 1, 2016 (MOD 6/2390);
• Viking DHC-6 Twin Otter Technical Bulletin. V6/00100, Revision NC, dated February 20, 2017 (MOD 6/2393); and
• Viking DHC-6 Twin Otter Technical Bulletin V6/00152, Revision NC, dated January 29, 2021 (MOD 6/2464).
This proposed AD would require accomplishing the actions described in the service information previously.
The FAA estimates that this AD, if adopted as proposed, would affect 4 airplanes of U.S. registry. The average labor rate is $85 per work-hour.
The FAA estimates the following costs to comply with this AD:
The extent of corrosion damage found during the inspections may vary significantly from airplane to airplane. The FAA has no way of determining how much corrosion damage may be found on each airplane, the cost for repairing corrosion damage on each airplane, or the number of airplanes that may require repair.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by March 7, 2022.
None.
This AD applies to Viking Air Limited (type certificate previously held by Bombardier Inc. and de Havilland, Inc.) Model DHC-6-400 airplanes, serial numbers 845 through 957, certificated in any category.
Joint Aircraft System Component (JASC) Code 2800, Aircraft Fuel System.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as corrosion of fuel system components located in the fuel gallery due to inadequate corrosion protection. The FAA is issuing this AD to prevent corrosion-related damage to fuel system components, which could lead to fuel leaks, electrical arcing, loss of fuel boost pump function, and erroneous fuel quantity readings. This unsafe condition, if not corrected, could result in fuel starvation with loss of engine power and increased risk of an in-flight fire with consequent loss of airplane control.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 50 hours time-in-service (TIS) after the effective date of this AD or within 3 months after the effective date of this AD, whichever occurs first, and thereafter at intervals not to exceed 125 hours TIS, do the following actions:
(i) Remove all fuel gallery covers and rinse the fuel gallery with water.
(ii) Inspect the fuel gallery for corrosion and, if there is any corrosion, take all necessary corrective actions before further flight by following Item D.15(2) of Special Inspection 3 in Temporary Revision No. 241, dated July 27, 2021, to the Viking DHC-6 Inspection Requirements Manual, PSM 1-6-7.
(2) Within 12 months after the effective date of this AD, install the modifications applicable to your airplane serial number by following the Accomplishment Instructions, sections A. through E. in Viking Air Limited, DHC-6 Twin Otter Service Bulletin V6/0044, Revision `B', dated September 13, 2021 (Viking SB V6/0044, Revision `B').
Within 12 months after the airplane is modified to operate on floats, regardless of whether the landing gear is later modified back to non-float landing gear, install the modifications applicable to your airplane serial number by following the Accomplishment Instructions, sections A. through E. in Viking SB V6/0044, Revision `B.'
(1) The Manager, New York ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Joseph Catanzaro, Aviation Safety Engineer, FAA, New York ACO Branch, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590; phone: (516) 228-7366; fax: (516) 794-5531; email:
(2) For service information identified in this AD, contact Viking Air Limited Technical Support, 1959 de Havilland Way, Sidney, British Columbia, Canada, V8L 5V5; phone: (North America) (800) 663-8444; fax: (250) 656-0673; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for all Leonardo S.p.a. Model AW109SP helicopters. This proposed AD was prompted by reports of corrosion inside the hoist support assembly (boom assembly) (affected part) that affects both the huck bolt heads (blind bolt fasteners) and the support surface. This proposed AD would require repetitive inspections of the external and internal surfaces of each affected part for cracking and corrosion and, depending on the findings, accomplishment of corrective actions, as specified in a European Union Aviation Safety Agency (EASA) AD, which is proposed for incorporation by reference (IBR). This proposed AD would also allow the installation of an affected part, provided certain instructions are followed. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by March 7, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For EASA material that is proposed for IBR in this AD, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
You may examine the AD docket at
Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email
EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2021-0179, dated July 27, 2021 (EASA AD 2021-0179) to correct an unsafe condition for Leonardo S.p.A. Helicopters, formerly Finmeccanica S.p.A., AgustaWestland S.p.A., and Agusta S.p.A., Model AW109SP helicopters, all serial numbers.
This proposed AD was prompted by reports of corrosion inside the hoist support assembly affecting both the huck bolt heads and the support surface. Investigation of the root cause for the corrosion is ongoing. The FAA is proposing this AD to address corrosion on the hoist support assembly. This condition, if not addressed, could affect the structural integrity of the hoist support assembly, leading to in-flight detachment of the hoist support and consequent damage to the helicopter, and injury to hoisted persons. See EASA AD 2021-0179 for additional background information.
EASA AD 2021-0179 requires repetitive inspections of the external and internal surfaces of each affected part for cracking and corrosion and, depending on the findings, accomplishment of corrective actions. If there is no evidence of corrosion on the interior surface of the boom torque tube or on the huck bolt heads, the corrective actions include spraying the interior surface with corrosion preventative compound around the hulk bolt heads from the forward and aft ends of the boom torque tube, and installing new tube plugs on both ends of the boom torque tube. If there is superficial corrosion on the interior surface of the boom torque tube or on the hulk bolt heads, the corrective actions include cleaning the corrosion, spraying the interior surface with corrosion preventative compound, and installing new tube plugs on both ends of the boom torque tube. If corrosion is found that is not superficial corrosion, the corrective action is repair or replacement of the boom torque tube.
If cracking is observed on the external surface of the hoist support assembly the corrective action is replacement of the hoist support assembly. If only corrosion is found on the external surface of the hoist support assembly the corrective actions include cleaning the hoist support assembly.
EASA AD 2021-0179 also allows installing an affected part, provided certain instructions are followed.
This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
These helicopters have been approved by EASA and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with the European Union, EASA has notified the FAA about the unsafe condition described in its AD. The FAA is proposing this AD after evaluating all known relevant information and determining that the unsafe condition described previously is likely to exist or develop on other helicopters of the same type design.
This proposed AD would require accomplishing the actions specified in EASA AD 2021-0179, described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this proposed AD.
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, the FAA proposes to incorporate EASA AD 2021-0179 by reference in the FAA final rule. This proposed AD would, therefore, require compliance with EASA AD 2021-0179 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this proposed AD. Using common terms that are the same as the heading of a particular section in EASA AD 2021-0179 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2021-0179. Service information referenced in EASA AD 2021-0179 for compliance will be available at
The FAA considers this proposed AD would be an interim action. If final action is later identified, the FAA might consider further rulemaking.
The FAA estimates that this AD, if adopted as proposed, would affect 40 helicopters of U.S. Registry. The FAA estimates the following costs to comply with this proposed AD.
The FAA estimates the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. The agency has no way of determining the number of aircraft that might need these replacements:
The FAA has received no definitive data on which to base the cost estimates for the repairs specified in this proposed AD.
The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected operators.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by March 7, 2022.
None.
This AD applies to all Leonardo S.p.a. Model AW109SP helicopters, certificated in any category.
Joint Aircraft Service Component (JASC) Code: 2560, Emergency Equipment.
This AD was prompted by reports of corrosion inside the hoist support assembly (boom assembly) (affected part) that affects both the huck bolt heads (blind bolt fasteners) and the support surface. The FAA is issuing this AD to address corrosion on the hoist support assembly. This condition, if not addressed, could affect the structural integrity of the hoist support assembly, leading to in-flight detachment of the hoist support and consequent damage to the helicopter, and injury to hoisted persons.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, European Union Aviation
(1) Where EASA AD 2021-0179 requires compliance in terms of flight hours, this AD requires using hours time-in-service.
(2) Where EASA AD 2021-0179 refers to its effective date, this AD requires using the effective date of this AD.
(3) Where the service information referenced in EASA AD 2021-0179 specifies discarding parts, this AD requires removing those parts from service.
(4) Where the service information referenced in EASA AD 2021-0179 specifies returning a part to the manufacturer, this AD requires removing that part from service.
(5) Where the service information referenced in EASA AD 2021-0179 specifies submitting photographs to the manufacturer, this AD does not require that action.
(6) Where the service information referenced in EASA AD 2021-0179 specifies attaching a label to the hoist support assembly, this AD does not require that action.
(7) Where paragraph (2) of EASA AD 2021-0179 specifies contacting Leonardo S.p.a. for corrective action instructions, this AD requires replacing or repairing before further flight using a method approved by the Manager, General Aviation and Rotorcraft Section, International Validation Branch, FAA; or EASA; or Leonardo S.p.a.'s EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
(8) This AD does not mandate compliance with the “Remarks” section of EASA AD 2021-0179.
Although the service information referenced in EASA AD 2021-0179 specifies to submit certain information to the manufacturer, this AD does not include that requirement.
Special flight permits may be permitted provided that there are no passengers on board.
(1) The Manager, International Validation Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the International Validation Branch, send it to the attention of the person identified in paragraph (l)(2) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For EASA AD 2021-0179, contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
(2) For more information about this AD, contact Andrea Jimenez, Aerospace Engineer, COS Program Management Section, Operational Safety Branch, Compliance & Airworthiness Division, FAA, 1600 Stewart Ave., Suite 410, Westbury, NY 11590; telephone (516) 228-7330; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to adopt a new airworthiness directive (AD) for certain Bell Textron Inc. Model 205A, 205A-1, 205B, 210, 212, 412, 412CF, and 412EP helicopters with a certain part-numbered tailboom left hand fin spar cap (spar cap) installed. This proposed AD was prompted by reports of cracked spar caps. This proposed AD would require inspecting each spar cap and depending on the inspection results, removing the spar cap from service. The FAA is proposing this AD to address the unsafe condition on these products.
The FAA must receive comments on this proposed AD by March 7, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Bell Textron, Inc., P.O. Box 482, Fort Worth, TX 76101; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-433-0272; email
You may examine the AD docket at
Ameet Shrotriya, Aviation Safety Engineer, DSCO Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177-1524; phone: (817) 222-5525; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Ameet Shrotriya, Aviation Safety Engineer, DSCO Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177-1524; phone: (817) 222-5525; email:
The FAA is proposing to adopt a new AD for certain serial-numbered Bell Textron Inc. Model 205A, 205A-1, 205B, 210, 212, 412, 412CF, and 412EP helicopters with a spar cap part number (P/N) 212-030-447-117 installed. This proposed AD was prompted by multiple reports of fatigue cracking in the spar caps. Metallurgical lab reports identified that the cracks originate at the rivet holes, possibly from mechanical damage caused during deburring. This condition, if not addressed, could result in reduced structural integrity of the helicopter and subsequent loss of control of the helicopter.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed the following Bell Alert Service Bulletins, each dated April 15, 2020 (ASB):
• ASB 205-20-116 for Model 205A and 205A-1 helicopters, serial numbers (S/N) 30001 through 30065, 30067 through 30165, 30167 through 30187, 30189 through 30296, and 30298 through 30332;
• ASB 205B-20-69 for Model 205B helicopters, S/N 30066, 30166, 30188, and 30297;
• ASB 210-20-13 for all serial-numbered Model 210 helicopters;
• ASB 212-20-162 for Model 212 helicopters, S/N 30502 through 30603, 30611 through 30999, 31101 through 31311, 32101 through 32142, and 35001 through 35103;
• ASB 412-20-180 for Model 412 and 412EP helicopters, S/N 33001 through 33213, 34001 through 34036, 36001 through 36999, 37002 through 37999, 38001 through 38999, and 39101 through 39999; and
• ASB 412CF-20-67 for Model 412CF helicopters, S/N 46400 through 46499.
Bell received a report of a fractured fin spar cap that occurred at vertical fin station (F.S.) 71 through the first rivet hole attaching the skin to the spar cap. Bell states that if undetected, the fin spar cap cracking may lead to additional structural damage. Each ASB specifies procedures for inspecting both flanges of the spar cap between F.S. 50 and F.S. 71 for cracks, loose rivets, and other damage using a 10x magnifying glass and flashlight and inspecting the exterior of the fin skin where it contacts the spar cap for cracks, loose rivets, and/or distortion. If no cracks or other damage are found, each ASB specifies returning the helicopter to service; if a crack or other damage is found, each ASB specifies contacting Bell's Product Support Engineering before further flight. Additionally, each ASB specifies that these inspections are to be accomplished within the next 100 flight hours or 90 days after the ASB's release, whichever occurs first, and every 100 flight hours thereafter.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in
This proposed AD would require, within 100 hours time-in-service (TIS) after the effective date of the AD, and thereafter at intervals not to exceed 100 hours TIS, using a 10x or higher power magnifying glass and flashlight, inspecting both flanges of the spar cap for any crack, loose rivet, and other damage (such as a scratch, dent, spalling, or corrosion). This proposed AD would also require inspecting the exterior of the fin skin in the area where it contacts the spar cap for any crack, loose rivet, and distortion. If there is any crack, loose rivet, or other damage in either flange, or if there is any crack, loose rivet, or distortion in the fin skin area, removing the spar cap from service would be required before further flight.
The ASBs specify contacting Bell if there is a crack or other damage, where as this proposed AD would not. The ASBs also specify the compliance time for the initial inspection is within 100 flight hours or 90 days after April 15, 2020, whichever occurs first; whereas the initial inspection in this proposed AD would be required within 100 hours TIS after the effective date of this AD.
The FAA considers that this proposed AD would be an interim action. The design approval holder may develop a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, the FAA might consider additional rulemaking.
The FAA estimates that this AD, if adopted as proposed, would affect 226 helicopters of U.S. registry. The FAA estimates the following costs to comply with this proposed AD, using an average labor rate of $85 per work-hour.
Each inspection would take about 1 work-hour, and there would be no parts costs, for an estimated cost of $85 per inspection and $19,210 for the U.S. fleet per inspection cycle. Replacing a spar cap, if required, would take about 50 work-hours and parts costs would be about $2,000, for an estimated cost of $6,250 per spar cap replacement.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA
The FAA determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) by March 7, 2022.
None.
This AD applies to the following Bell Textron Inc. helicopters certificated in any category, with a tailboom left hand fin spar cap (spar cap) part number 212-030-447-117 installed.
(1) Model 205A and 205A-1 helicopters, serial number (S/N) 30001 through 30065 inclusive, 30067 through 30165 inclusive, 30167 through 30187 inclusive, 30189 through 30296 inclusive, and 30298 through 30332 inclusive;
(2) Model 205B helicopters, S/N 30066, 30166, 30188, and 30297;
(3) Model 210 helicopters, all S/Ns;
(4) Model 212 helicopters, S/N 30502 through 30603 inclusive, 30611 through 30999 inclusive, 31101 through 31311 inclusive, 32101 through 32142 inclusive, and 35001 through 35103 inclusive;
(5) Model 412 and 412EP helicopters, S/N 33001 through 33213 inclusive, 34001 through 34036 inclusive, 36001 through 36999 inclusive, 37002 through 37999 inclusive, 38001 through 38999 inclusive, and 39101 through 39999 inclusive; and
(6) Model 412CF helicopters, S/N 46400 through 46499 inclusive.
Joint Aircraft System Component (JASC) Code 5302, Rotorcraft Tail Boom.
This AD was prompted by the discovery of fatigue cracking in the spar cap. A crack in the spar cap, if not detected and corrected, could create stress concentrations at the edge of the rivet holes, resulting in reduced structural integrity of the helicopter and subsequent loss of control of the helicopter. The FAA is issuing this AD to detect and prevent this unsafe condition.
Comply with this AD within the compliance times specified, unless already done.
Within 100 hours time-in-service (TIS) after the effective date of this AD, and thereafter at intervals not to exceed 100 hours TIS:
(1) Using a 10x or higher power magnifying glass and a flashlight, inspect both flanges of the spar cap between fin station (F.S.) 50 and F.S. 71 for any crack, loose rivet, and other damage such as a scratch, dent, spalling, or corrosion, as depicted in Figure 1 of Bell Alert Service Bulletin (ASB) 205-20-116, ASB 205B-20-69, ASB 210-20-13, ASB 212-20-162, ASB 412-20-180, or ASB 412CF-20-67, each dated April 15, 2020, as applicable to your helicopter. If either spar cap flange is cracked, has a loose rivet, or has other damage, remove the spar cap from service before further flight.
(2) Inspect the exterior of the fin skin in the area that contacts the spar cap for any crack, loose rivets, and distortion. If there is any crack, loose rivet, or distortion in the fin skin in the area that contacts the spar cap, remove the spar cap from service before further flight.
(1) The Manager, DSCO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in Related Information.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(1) For more information about this AD, contact Ameet Shrotriya, Aviation Safety Engineer, DSCO Branch, Compliance & Airworthiness Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177-1524; phone: (817) 222-5525; email:
(2) For service information identified in this AD, contact Bell Textron, Inc., P.O. Box 482, Fort Worth, TX 76101; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-433-0272; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede Airworthiness Directive (AD) 2017-24-10, which applies to certain The Boeing Company Model 757-200, -200PF, and -300 series airplanes. AD 2017-24-10 requires repetitive inspections for any cracking of a certain fuselage frame inner chord; identification of the material of a certain fuselage frame inner chord for certain
The FAA must receive comments on this proposed AD by March 7, 2022.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
You may examine the AD docket at
Peter Jarzomb, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5234; email:
The FAA invites you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under
Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to
CBI is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to this NPRM contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this NPRM, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this NPRM. Submissions containing CBI should be sent to Peter Jarzomb, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5234; email:
The FAA issued AD 2017-24-10, Amendment 39-19114 (82 FR 57343, December 5, 2017) (AD 2017-24-10), for certain The Boeing Company Model 757-200, -200PF, and -300 series airplanes. AD 2017-24-10 was prompted by reports of cracking found at a certain fuselage frame inner chord. AD 2017-24-10 requires repetitive inspections for any cracking of a certain fuselage frame inner chord; identification of the material of a certain fuselage frame inner chord for certain airplanes; and applicable corrective actions. The agency issued AD 2017-24-10 to detect and correct such cracks, which could result in the cargo door opening during flight, and result in rapid decompression of the airplane and the inability to sustain loads required for continued safe flight and landing.
Since the FAA issued AD 2017-24-10, the FAA has received reports of new crack findings outside of the AD 2017-24-10 inspection area, which the existing inspections will not detect. An operator was accomplishing Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016, which is the service information required by AD 2017-24-10) on a certain The Boeing Company Model 757-200 airplane and found four cracks ranging from 0.10 to 2.00 inches in length in the station (STA) 1380 frame web and two cracks ranging from 1.00 to 2.12 inches in length in the frame inner chord. The airplane had 23,005 total flight cycles at the time of the crack findings. The frame web was made from 0.09 inch thick 2024-T3 aluminum, and the inner chord was made from 7075-T73 aluminum. Based on the length of the crack in the web at the time of discovery, the cracks in the frame may have initiated in the 2024-T3 web, and would have been hidden behind the guide track fitting. If the cracks start in the frame web, existing Maintenance Planning Data (MPD) and Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016, inspections do not provide sufficient opportunities to find cracks in the STA 1380 frame before the critical crack length is reached, resulting in an airplane-level safety issue.
In addition, the FAA has received five reports of crack findings in airplanes with production line numbers 1-57, which are made with 7075 material for the inner and outer chord and the frame web. Those airplanes may also have a thinner web gauge than that in airplanes with line numbers 58 and subsequent. Existing inspections for these airplanes do not remove the guide track fitting at STA 1380, and therefore do not provide sufficient opportunity to detect cracks
The root cause for the cracking in the STA 1380 frame inner chord and web under the roller guide track fitting is attributed to the out-of-plane bending stress induced from a mis-rigging condition of the No. 2 cargo door, which allows the roller pin on the lower cargo door to contact the roller guide track fitting. The new proposed repetitive inspections include removing the guide track fitting to inspect for any crack. The FAA is issuing this AD to detect and correct such cracks, which could result in rapid decompression of the airplane and the inability to sustain loads required for continued safe flight and landing.
The FAA is issuing this NPRM after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.
The FAA reviewed Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021. This service information specifies procedures for a general visual inspection or a maintenance records check of the STA 1380 frame for any repair, and repetitive surface high frequency eddy current (HFEC) inspections of the STA 1380 frame inner chord and frame web for any cracking, repetitive sub-surface low frequency eddy current (LFEC) inspections of the STA 1380 frame inner chord for any cracking, and applicable corrective actions. Corrective actions include repair.
This AD would also require Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016, which the Director of the Federal Register approved for incorporation by reference as of January 9, 2018 (82 FR 57343, December 5, 2017).
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This proposed AD would retain all requirements of AD 2017-24-10. This proposed AD would add new airplanes and would require new inspection types in certain areas, an expanded inspection area, additional inspections, and applicable corrective actions. This proposed AD would require accomplishment of the actions identified in Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021, described previously, except for any differences identified as exceptions in the regulatory text of this proposed AD.
Accomplishment of the applicable initial inspections and corrective actions specified in the Accomplishment Instructions of Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021, terminates the inspections required by paragraphs (g) and (h) of this proposed AD.
For information on the procedures and compliance times, see this service information at
The FAA estimates that this AD, if adopted as proposed, would affect 477 airplanes of U.S. registry. The FAA estimates the following costs to comply with this proposed AD:
The FAA has received no definitive data on which to base the cost estimates for the on-condition repairs specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
The FAA has determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Would not affect intrastate aviation in Alaska, and
(3) Would not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
The FAA must receive comments on this airworthiness directive (AD) action by March 7, 2022.
This AD replaces AD 2017-24-10, Amendment 39-19114 (82 FR 57343, December 5, 2017) (AD 2017-24-10).
This AD applies to all The Boeing Company Model 757-200, -200PF, -200CB, and -300 series airplanes, certificated in any category.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of cracking found at the fuselage station (STA) 1380 frame inner chord and by reports of new crack findings outside of the AD 2017-24-10 inspection area, which the existing inspections will not detect. The FAA is issuing this AD to detect and correct such cracks, which could result in rapid decompression of the airplane and the inability to sustain loads required for continued safe flight and landing.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2017-24-10, with no changes. For Group 1 airplanes as identified in Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016: At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016; except as specified in paragraph (i)(1) of this AD, do a surface high frequency eddy current (HFEC) inspection for any cracking of the fuselage STA 1380 frame inner chord, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016; except as specified in paragraph (i)(2) of this AD. Do all applicable corrective actions before further flight. Repeat the surface HFEC inspection, thereafter, at the times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016.
This paragraph restates the requirements of paragraph (h) of AD 2017-24-10, with no changes. For Group 2 airplanes as identified in Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016: At the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016, except as specified in paragraph (i)(1) of this AD, identify the material of the fuselage STA 1380 frame inner chord, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016.
(1) If the fuselage STA 1380 frame inner chord material 2024-T42 aluminum alloy is found during any identification required by paragraph (h) of this AD: No further action is required by this paragraph for that airplane.
(2) If the fuselage STA 1380 frame inner chord material 7075-T73 aluminum alloy is found during any identification required by the introductory text of paragraph (h) of this AD: Before further flight, do a surface HFEC inspection for any cracking of the fuselage STA 1380 frame inner chord, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016; except as specified in paragraph (i)(2) of this AD. Do all applicable corrective actions before further flight. Repeat the surface HFEC inspection thereafter at the times specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016.
This paragraph restates the requirements of paragraph (i) of AD 2017-24-10, with no changes.
(1) Where Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after January 9, 2018 (the effective date of AD 2017-24-10).
(2) Where Boeing Alert Service Bulletin 757-53A0101, dated November 8, 2016, specifies to contact Boeing for appropriate action and identifies that action as “RC” (Required for Compliance): Before further flight, repair the crack using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
Except as specified by paragraph (k) of this AD: At the applicable times specified in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021, do all applicable actions identified in, and in accordance with, the Accomplishment Instructions of Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021.
(1) Where the Compliance Time column of the tables in the “Compliance” paragraph of Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021, uses the phrase “the original issue date of the Requirements Bulletin 757-53A0118 RB,” this AD requires using “the effective date of this AD.”
(2) Where Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021, specifies contacting Boeing for repair instructions or for alternative inspections: This AD requires doing the repair, or doing the alternative inspections and applicable on-condition actions using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
Accomplishment of the applicable initial inspections and corrective actions specified in the Accomplishment Instructions of Boeing Alert Requirements Bulletin 757-53A0118 RB, dated October 22, 2021, terminates the inspections required by paragraphs (g) and (h) of this AD.
(1) The Manager, Los Angeles ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or responsible Flight Standards Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (n)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector,
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by The Boeing Company Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO Branch, FAA, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) AMOCs approved previously for AD 2017-24-10 are not approved as AMOCs with this AD.
(5) Except as specified by paragraph (i) of this AD: For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (m)(5)(i) and (ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Peter Jarzomb, Aerospace Engineer, Airframe Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5234; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA, the Agency, or we) is proposing to classify Human Leukocyte Antigen (HLA), Human Platelet Antigen (HPA), and Human Neutrophil Antigen (HNA) devices, a generic type of device, into class II (special controls). FDA is identifying proposed special controls for HLA, HPA, and HNA devices that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that we do not intend to exempt these device types from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA is publishing in this document the recommendations of the Blood Products Advisory Committee, serving as a device classification panel, regarding the classification of these devices. After considering public comments on the proposed classification, FDA will publish a final regulation classifying these device types.
Submit either electronic or written comments on the proposed rule by April 21, 2022.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 21, 2022. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The
Myrna Hanna, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is proposing to classify HLA, HPA, and HNA devices, a generic type of device, into class II (special controls). The Agency believes that the special controls established by this proposed rule, together with general controls, would provide reasonable assurance of the safety and effectiveness of these devices. FDA is also giving notice that we do not intend to exempt HLA, HPA, and HNA devices from premarket notification requirements of the FD&C Act.
FDA is proposing to classify HLA, HPA, and HNA devices, a generic type of device, into class II with special controls. This proposed rule provides device descriptions that include indications for use of the devices and the special controls that will provide reasonable assurance of the safety and effectiveness of these devices.
FDA is proposing this action under the device provisions of the FD&C Act including section 513 of the FD&C Act (21 U.S.C. 360c).
The benefits of this proposed rule consist of the cost savings resulting from the reduction in regulatory and economic burden that accompanies the decrease in the number of information requests and incomplete submissions submitted by manufacturers and handled by FDA; however, we lack the information needed that would allow us to quantify these benefits. The number of requests for additional information following manufacturers' 510(k) submissions is small and widely dispersed over the duration of time these devices have been marketed. The classification procedure and outlined special controls will be helpful for HLA, HPA, and HNA manufacturers in preparing their submissions. Further benefits may be derived from the decreased time a notification submission will need to be reviewed and the subsequent potential benefits realized by consumers and manufacturers.
The costs of this proposed rule include one-time upfront labeling redesigns, in addition to initial learning and reading costs. The total estimated one-time costs of this proposed rule are $434,885 (in 2020 dollars). The present value of these costs is $434,885 because they are one-time costs that are expected to occur in the first year. The annualized cost of this proposed rule over 10 years is $54,201 at a seven percent discount rate and $45,632 at a three percent discount rate.
The FD&C Act (21 U.S.C. 301
Class I devices are those devices for which the general controls of the FD&C Act (controls authorized by or under sections 501, 502, 510, 516, 518, 519, or 520 (21 U.S.C. 351, 352, 360, 360f, 360h, 360i, or 360j) or any combination of such sections) are sufficient to provide reasonable assurance of safety and effectiveness of the device; or those devices for which insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance, but because the devices are not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, are to be regulated by general controls (section 513(a)(1)(A) of the FD&C Act).
Class II devices are those devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions the Agency deems necessary to provide such assurance (section 513(a)(1)(B) of the FD&C Act).
Class III devices are those devices for which insufficient information exists to determine that general controls and special controls would provide a reasonable assurance of safety and effectiveness, and are purported or represented for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury (section 513(a)(1)(C) of the FD&C Act).
Under section 513(d)(1) of the FD&C Act, devices that were in commercial distribution before the enactment of the Medical Device Amendments of 1976 (1976 amendments) on May 28, 1976 (generally referred to as “preamendments devices”), are classified after FDA: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2) publishes the panel's recommendation, along with a proposed regulation classifying the device, and provides an opportunity for interested persons to submit comments; and (3) publishes a final regulation classifying the device.
FDA has classified most preamendments devices under these procedures, relying upon valid scientific evidence as described in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c), to determine that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.
Devices that were not in commercial distribution before May 28, 1976 (generally referred to as “postamendments devices”), are classified automatically by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: (1) FDA classifies or reclassifies the device into class I or II or (2) FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval.
The Agency determines whether new devices are substantially equivalent to previously marketed devices by means of premarket notification procedures in section 510(k) of the FD&C Act and part 807 of the regulations (21 CFR part 807). The 510(k) premarket notification is a submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as (
A person may market a preamendments device that has been classified into class III through premarket notification procedures without submission of a premarket approval application until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.
The first product license for Leukocyte Typing Serum was issued in December 1974, by the Bureau of Biologics, FDA. An FDA guideline for the production, testing, and lot release of Leukocyte Typing Serum was issued in 1977 and subsequently codified as Additional Standards in the biologics regulations under 21 CFR 660.10 through 660.15.
In the
In the
Since 1982, FDA has cleared approximately 100 HLA device premarket notifications (510(k)) submissions. Since 1993, FDA has cleared seven HPA assays through the 510(k) premarket notifications pathway. Five devices were cleared for the detection of antibodies against HPA and two were cleared for HPA typing. Since 2006, FDA has cleared four HNA devices through the 510(k) premarket
On September 15, 2000, the Blood Products Advisory Committee (BPAC) (2000 BPAC), serving as a device classification panel, provided recommendations to FDA regarding the classification of in vitro diagnostic reagents and kits for use in determining the HLA phenotype or genotype of an individual, or for detecting antibodies to HLA antigens (Ref. 1). The scope of the discussion included devices that are used to support platelet and leukocyte transfusions, or organ and stem cell transplantation. The classification of HLA kits used to predict disease was not discussed at the meeting. The 2000 BPAC agreed unanimously that HLA devices should be classified as class II medical devices. The panel did not agree that the devices should be exempt from the requirement to submit a 510(k). Although the 2000 BPAC recommended classification of the HLA devices as class II, the classification was not finalized by FDA because of competing priorities.
On November 30, 2017, FDA sought recommendations from the BPAC, serving as a device classification panel (the Panel) (Refs. 2 and 3), to discuss the classification of HLA, HPA, and HNA devices. FDA proposed to the Panel that HLA, HPA, and HNA devices be classified as a generic device type. The rationale to classify these devices together was based on the similarities in the biological properties of the three antigen systems, the use of similar technologies for the detection of antigens and antibodies, the clinical use of the test results, and the special controls required to mitigate risks. FDA proposed that these are devices that do not differ significantly in purpose, design, materials, energy source, function, or other features related to safety and effectiveness, and for which similar regulatory controls are sufficient to provide reasonable assurance of safety and effectiveness. The Panel recommended that these devices be classified into class II (special controls) with premarket review. FDA is not aware of new information that has arisen since the Panel meeting that would provide a basis for different recommendations or finding. The recommendations of the Panel are summarized in Section V.
We are issuing this proposed rule under section 513(a) of the FD&C Act. FDA has authority under this provision of the FD&C Act to issue a regulation to establish special controls for class II devices for which general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance. Under this authority, FDA is establishing special controls for HLA, HPA, and HNA devices.
This section summarizes the Panel's deliberations on November 30, 2017.
FDA described HLA, HNA, and HPA devices for the Panel's consideration:
Human Leukocyte, Neutrophil and Platelet antigen and antibody devices consist of HLA, HNA, and HPA typing and antibody detection devices.
• HLA typing devices are used to determine HLA types, to aid in transfusion or transplantation donor and recipient matching, or to aid in the diagnosis of diseases.
• HLA antibody detection devices are used to detect antibodies to HLA antigens to aid in donor and recipient matching in transfusion or transplantation.
• HPA typing devices are used for the detection of human platelet antigens to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
• HPA antibody detection devices are used to detect autoantibodies and alloantibodies against platelet glycoproteins to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
• HNA typing devices are used for the detection of human neutrophil antigens to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
• HNA antibody detection devices are used to detect autoantibodies and alloantibodies against neutrophil antigens to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
FDA clarified the following devices are not included in the proposed classification:
• HLA, HPA, or HNA devices used as a companion diagnostic device, a device that provides information that is essential for the safe and effective use of a corresponding therapeutic product.
• HLA, HPA, or HNA assays that are intended for clinical use and designed, manufactured, and used within a single laboratory.
The Panel recommended that HLA, HNA, and HPA devices be classified into class II with special controls with premarket review. The Panel agreed that general controls were not sufficient to provide reasonable assurance of safety and effectiveness of HLA, HPA, and HNA devices. The Panel believed that HLA, HPA, and HNA devices present a potentially unreasonable risk of illness, injury, or death. Considering these risks, the Panel agreed that sufficient information exists to establish special controls for these devices. Consequently, the consensus of the Panel was that class II classification (special controls) and premarket review would provide reasonable assurance of safety and effectiveness of these devices.
The Panel considered the following valid scientific evidence to make their recommendation regarding the safety and effectiveness of these devices under its conditions of use. Specifically, the Panel considered the history of safety and effectiveness of HLA, HPA, and HNA devices over many years of use; the results of an FDA review of the scientific literature; medical device reports (MDRs) of adverse events or malfunctions; device recalls, and FDA's regulatory experiences with the devices.
As required by section 513(d)(1) of the FD&C Act, FDA provided to the Panel the following summary of valid scientific evidence regarding the benefits and risks of HLA, HPA, and HNA devices. A systemic literature review indicates that the use of these devices has improved patient care in transfusion and transplantation, and in disease diagnosis. HLA matching between the donor and recipient is a key strategy to reduce rejection. The presence of anti-HLA antibodies, especially donor-specific antibodies, has been associated with worse outcomes after transplantation or transfusion. Identification of HLA antibodies allows for informed decisions regarding whether to accept and transplant an organ for a specific recipient. In similar fashion, HPA and HLA devices provide a means to detect and identify related antigens and antibodies facilitating transfusion with compatible blood (platelet) products. In addition, HNA and HLA devices provide laboratorians and clinicians tools to investigate transfusion-related acute lung injury (TRALI) reactions and/or mitigate the risk of future TRALI reactions associated with implicated blood donors.
However, available literature, MDRs, and medical device recall data indicate that HLA, HPA, and HNA devices can malfunction. These devices may generate false positive, false negative, or inconsistent results and have the potential to cause adverse health consequences. Suspected device-associated deaths, serious injuries, and malfunctions are reported to FDA through the Manufacturer and User Facility Device Experience (MAUDE) database. Prior to the Panel meeting, FDA conducted queries of the MAUDE database to identify MDRs related to the use of HLA, HPA, and HNA devices. The search was restricted to reports that FDA received and entered into the database before May 1, 2017. There were 477 MDRs for HLA devices. Most MDRs (464) were reported for HLA genotyping devices, while 13 MDRs were reported for HLA antibody detection devices. All MDRs with reportable category information are malfunctions. The most frequent malfunctions are incorrect reactivity assignments that lead to mistype or no type HLA results. There have been no reported deaths or serious injuries related to these malfunctions. These medical device reports suggest that 510(k) premarket notification of HLA devices is a necessary means to minimize adverse health consequences that may result from HLA device malfunctions. Compared to HLA devices, there are few HPA and HNA devices in the U.S. market and few reported MDRs. The queries of the MAUDE database prior to the Panel meeting identified only two MDRs for HPA devices and no MDRs for HNA devices. However, these devices share similar technologies and clinical applications to HLA devices and have the potential for malfunctions that may cause adverse health consequences. Therefore, 510(k) premarket notification of HPA and HNA devices is needed to minimize adverse health consequences that may result from HPA or HNA device malfunction.
Similarly, prior to the Panel meeting, FDA searched the Medical Device Recalls database for all recalls received before May 1, 2017, for these devices. Of the total 37 HLA device recalls, none were classified as class I recalls, in which the violative product could cause serious adverse health consequences or death. A total of 19 recalls were classified as class II, and 18 were classified as class III. Most of the recalls (32 of 37) were for products that failed to provide correct testing results (false negative, false positive, mistype, or no type). The root causes leading to incorrect HLA typing results include incorrect reactivity assignments, lack of testing sample(s) with specific allele before releasing, and manufacturing errors. The HLA antibody device recalls were due to manufacturing errors during the production of recombinant HLA proteins, such as unstable transfectant. No recalls were reported for HPA and HNA devices. However, these devices share similarities with the HLA devices and are likely prone to similar malfunctions.
FDA presented the following risks to health associated with HLA, HPA, and HNA devices: Patient injury or death due to: (1) Poor graft survival or function due to transplantation of incompatible hematopoietic cells, tissue, or organ; (2) graft rejection because of the transplantation of incompatible hematopoietic cells, tissue, or organ; (3) graft-versus-host disease because of the transplantation of incompatible immune system cells; (4) incorrect or delayed diagnosis of medically related conditions or assessment of future risk of adverse outcomes because of incorrect HLA, HPA, or HNA test results; (5) transfusion reaction (
FDA next proposed to the Panel measures to mitigate the risks to health associated with HLA, HNA, and HPA devices. The identified risks to health and the special controls to mitigate these risks (explained in the paragraph immediately after the table) are summarized in the following table:
FDA proposed the following special controls (cross-referenced in the table above) to the Panel for HLA, HPA, and HNA devices: (1) Premarket submissions must include detailed documentation of the following information: (a) Device accuracy study using well-characterized samples representing as many targets as possible; (b) precision studies to evaluate possible sources of variation that may affect test results; (c) comparison studies to evaluate the device's performance compared to a predicate; (d) specific information that addresses or mitigates risks associated with false positive antibody reactivity
The Panel members agreed with the special controls proposed by FDA.
After considering the recommendations of the Panel and the valid scientific evidence, including the
We are proposing to classify the devices as a generic type of device because of the similarities in the biological properties of the three antigen systems, the use of similar technologies for the detection of antigens and antibodies, the clinical use of the test results, and the special controls required to mitigate risks. The proposed device identification includes the indications for use of HLA, HPA, and HNA devices subject to the classification. The following devices are not included in the proposed classification: HLA, HPA, or HNA devices used as a companion diagnostic device, a device that provides information that is essential for the safe and effective use of a corresponding therapeutic product.
The proposed regulation also includes special controls that are necessary to provide a reasonable assurance of the safety and efficacy of the devices. When developing the special controls, we considered the recommendations provided in the FDA guidance document entitled “Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation” (Ref. 4).
Section 510(m) of the FD&C Act provides that a class II device may be exempted from premarket notification requirements under section 510(k) of the FD&C Act, if the Agency determines that premarket notification is not necessary to assure the safety and effectiveness of the device. The Agency does not intend to exempt HNA, HPA, and HNA devices from 510(k) premarket notification as allowed under section 510(m) of the FD&C Act. FDA believes premarket notification is necessary for these devices to assure their safety and effectiveness.
FDA proposes that any final regulation based on this proposal become effective 30 days after its date of publication in the
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because of the limited impact of this proposed rule, we propose to certify that the proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $158 million, using the most current (2020) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
If finalized, the proposed rule would classify HLA, Human HPA, and HNA devices as a generic group of devices into class II (special controls). The Agency believes that the special controls included in this proposed rule, together with general controls, are necessary to provide reasonable assurance of the safety and effectiveness of these devices. The special controls in the proposed rule are already generally practiced by manufacturers of currently cleared devices; the primary change consists of a labeling update. FDA is also giving notice that we do not intend to exempt HLA, HPA, and HNA devices from premarket notification requirements of the FD&C Act.
The proposed rule's costs are summarized in table 2; we are unable to quantify benefits for this proposed rule. Costs are calculated as the one-time costs of relabeling affected devices to comply with the proposed rule and costs associated with reading and understanding the proposed rule. The total estimated one-time costs of this rule are $434,885 (in 2020 dollars). The present value of these costs is $443,885 because they are one-time costs that are expected to occur in the first year. The annualized cost of this proposed rule over 10 years is $54,201 at a seven percent discount rate and $45,632 at a three percent discount rate.
The benefits of this proposed rule consist of the cost savings resulting from the reduction in regulatory and economic burden that accompanies the decrease in the number of information requests and incomplete submissions submitted by manufacturers and handled by FDA; however, we lack the information needed that would allow us to quantify these benefits. The number of requests for additional information following manufacturers' 510(k) submissions is small and widely dispersed over the duration of time these devices have been marketed. The classification procedure and outlined special controls would be helpful for HLA, HPA, and HNA manufacturers in preparing their submissions. Further benefits may be derived from the decreased time a notification submission would need to be reviewed and the subsequent potential benefits realized by consumers and manufacturers. The costs of this proposed rule include one-time upfront labeling redesigns, in addition to initial learning and reading costs.
Consistent with Executive Order 12866, table 2 provides the costs and a description of benefits for this proposed rule.
We have developed a comprehensive Preliminary Economic Analysis of Impacts that assesses the impacts of the proposed rule. The full analysis of economic impacts is available in the docket for this proposed rule (Ref. 5) and at
We have determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that this proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the proposed rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13175. We have tentatively determined that the proposed rule does not contain policies that would have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes. The Agency solicits comments from tribal officials on any potential impact on Indian Tribes from this proposed action.
The following references are on display at the Dockets Management Staff (see
1. Blood Products Advisory Committee Meeting transcript—September 15, 2000 (pp. 209-220), available at:
2. Blood Products Advisory Committee Meeting transcript—November 30, 2017, available at:
3. FDA Executive Summary. Classification of Human Leukocyte, Neutrophil and Platelet Antigen or Antibody Tests—November 30, 2017, available at:
4. “Recommendations for Premarket Notification (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation: Guidance for Industry,” July 2015, available at:
5. FDA, “Medical Devices; Immunology and Microbiology Devices; Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests,” Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis,” 2019 (available at
Biologics, Laboratories, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR part 866 be amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(1) HLA typing devices are used to determine HLA types, to aid in transfusion or transplantation donor and recipient matching, or to aid in the diagnosis of diseases.
(2) HLA antibody detection devices are used to detect antibodies to HLA antigens to aid in donor and recipient matching in transfusion or transplantation.
(3) HPA typing devices are used for the detection of human platelet antigens to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
(4) HPA antibody detection devices are used to detect autoantibodies and alloantibodies against platelet glycoproteins to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
(5) HNA typing devices are used for the detection of human neutrophil antigens to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
(6) HNA antibody detection devices are used to detect autoantibodies and alloantibodies against neutrophil antigens to aid in donor and recipient matching in blood transfusion or to aid in the diagnosis of diseases.
(b)
(1) Premarket submissions must include detailed documentation of the following:
(i) Device accuracy study using well-characterized samples representing as many targets as possible.
(ii) Precision studies to evaluate possible sources of variation that may affect test results.
(iii) Comparison studies to evaluate the device's performance compared to a predicate.
(iv) Specific information that addresses or mitigates risks associated with false positive antibody reactivity,
(v) Description of how the assay cutoff was established and validated as well as supporting data.
(vi) Documentation for device software, including, but not limited to, software requirement specifications, software design specifications,
(vii) Design specifications that are in place to prevent incorrect reactivity assignment or multiplex assays in which large numbers of probes and/or primers are handled during manufacturing process.
(viii) Description of a plan on how to ensure the performance characteristics of the device remain unchanged over time when new HLA alleles are identified and/or reactivity assignments are changed from the assignments at the time the device was evaluated.
(2) The device labeling must include:
(i) A limitation statement that reads, “The results should not be used as the sole basis for making a clinical decision.”
(ii) A warning that reads “The device has not been cleared or approved for use as a companion diagnostic.”
U.S. Army Corps of Engineers, DoD.
Notice of proposed rulemaking and request for comments.
The U.S. Army Corps of Engineers (Corps) is proposing to revise its regulations to establish a restricted area within the Richardson Training Area on Joint Base Elmendorf-Richardson (JBER), at Eagle River. The United States Army, Alaska (USARAK) G3/5/7 Training and Support Activity-Alaska (TSA-AK) requested establishment of a restricted area which would be located in the area of navigable waters extending from the span on Bravo Bridge across Eagle River to the mouth of Eagle River Knik Arm (Eagle River channel). Establishment of the restricted area would prevent all watercraft navigations and individuals from entering an active military range munitions impact area at all times, except for authorized vessels and individuals engaged in support of military training and management activities. This restricted area is necessary to avoid inadvertent entry into the impact area during live-fire weapons training, exposure to hazardous noise, and inadvertent encounters with unexploded ordnance.
Written comments must be submitted on or before February 22, 2022.
You may submit comments, identified by docket number COE-2021-0006, by any of the following methods:
Mr. David Olson, Headquarters, U.S. Army Corps of Engineers, Operations and Regulatory Community of Practice, Washington, DC at 202-761-4922.
Pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat 892; 33 U.S.C. 3) the Corps is proposing to amend the regulations at 33 CFR part 334 by establishing a restricted area in the Eagle River channel. The amendment to this regulation will allow the USARAK Commander to prevent all watercraft navigations and individuals from entering an active military range (Richardson Training Area, Joint Base Elmendorf-Richardson) munitions impact area at all times, except for authorized vessels and individuals engaged in support of military training and management activities. This restricted area will be in place as a precautionary measure to protect the public from inadvertently entering the impact area during live-fire weapons training, encountering hazardous noise in the vicinity of the impact area, and encountering unexploded ordnance.
a.
b.
The Corps certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities. The restricted area is necessary to protect public safety. This restricted regulation would prevent all watercraft and individuals from entering an activity military range munitions impact area at all times, except for authorized vessels and individuals engaged in support of military training and management activities. The regulation would allow people, watercraft, or vessels to enter or remain in the waters in the restricted area as long as they are authorized by the enforcing agency. Small entities can utilize navigable waters outside of the restricted area. Unless information is obtained to the contrary during the comment period, the Corps expects that the economic impact of the proposed restricted area would have practically no impact on the public, any anticipated navigational hazard or interference with existing waterway traffic. After considering the economic impacts of this restricted area regulation on small entities, I certify that this proposed rule would not have a significant impact on a substantial number of small entities.
c.
d.
Danger zones, Navigation (water), Restricted areas, Waterways.
For the reasons set forth in the summary above, the Corps proposes to amend 33 CFR part 334 as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
(a)
(b)
(c)
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a state implementation plan (SIP) revision formally submitted by the State of Delaware. This revision consists of the base year inventory for the Delaware portion of the Philadelphia-Wilmington-Atlantic City, PA-NJ-MD-DE marginal nonattainment area (Philadelphia Area) for the 2015 ozone national ambient air quality standards (NAAQS). This action is being taken under the Clean Air Act (CAA).
Written comments must be received on or before February 22, 2022.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2021-0854 at
Adam Yarina, Planning & Implementation Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-2103. Mr. Yarina can also be reached via electronic mail at
On October 9, 2020, the Delaware Department of Natural Resources and Environmental Control (DNREC) on behalf of the State of Delaware, submitted a revision to the Delaware SIP entitled, “2017 Base Year Emissions Inventory State Implementation Plan for VOC, NO
On October 1, 2015, EPA strengthened the 8-hour ozone NAAQS, lowering the level of the NAAQS from 0.075 ppm parts per million (ppm) to 0.070 ppm. See 80 FR 65292 (October 26, 2015). Effective August 3, 2018, EPA designated the Philadelphia Area, which consists of New Castle County in Delaware and counties in Maryland, New Jersey, and Pennsylvania, as marginal nonattainment for the 2015 ozone NAAQS. See 83 FR 25776 (June 4, 2018). CAA section 182(a)(1) requires ozone nonattainment areas classified as marginal or above to submit a comprehensive, accurate, current inventory of actual emissions from all emissions sources in the nonattainment area, known as a “base year inventory.” The New Castle County base year inventory SIP addresses a base year inventory requirement for the Philadelphia Area.
EPA's review of Delaware's base year inventory SIP indicates that it meets the base year inventory requirements for the 2015 ozone NAAQS. As required by 40 CFR 51.1315(a), DNREC selected 2017 for the base year inventory, which is consistent with the baseline year for the RFP because it is the year of the most recent triennial inventory. DNREC included actual ozone season emissions, pursuant to 40 CFR 51.1315(c).
EPA prepared a Technical Support Document (TSD) in support of this rulemaking. In that TSD, EPA reviewed the results, procedures, and methodologies for the SIP base year, and found them to be acceptable and developed in accordance with EPA's technical guidance. The TSD is available online at
In EPA's December 6, 2018 (83 FR 62998) rulemaking, “Implementation of the 2015 National Ambient Air Quality Standards for Ozone: Nonattainment Area State Implementation Plan Requirements,” known as the “SIP Requirements Rule,” EPA set out nonattainment area requirements for the 2015 ozone NAAQS. SIP Requirements Rule established base year inventory requirement, which were codified at 40 CFR 51.1315. As per 40 CFR 51.1315(a), each 2015 ozone nonattainment area is required to submit a base year inventory within 2 years of designation (
Also, 40 CFR 51.1315(a) requires that the inventory year be selected consistent with the baseline year for the reasonable further progress (RFP) plan as required by 40 CFR 51.1310(b), which states that the baseline emissions inventory shall be the emissions inventory for the most recent calendar year for which a complete triennial inventory is required to be submitted to the EPA under the provisions of subpart A of 40 CFR part 51, Air Emissions Reporting Requirements, 40 CFR 51.1 through 51.50. The most recent triennial inventory year conducted for the National Emissions Inventory (NEI) pursuant to the Air Emissions Reporting Requirements (AERR) rule is 2017. See
Furthermore, 40 CFR 51.1315(c) requires emissions values included in the base year inventory to be actual ozone season day emissions as defined by 40 CFR 51.1300(q), which states that ozone season day emissions means an average day's emissions for a typical ozone season work weekday. The state shall select, subject to EPA approval, the particular month(s) in the ozone season and the day(s) in the work week to be represented, considering the conditions assumed in the development of RFP plans and/or emissions budgets for transportation conformity.
The New Castle County base year inventory SIP contains an explanation of DNREC's 2017 base year emissions inventory for New Castle County (2017 New Castle County BYE) for point, non-point, and mobile anthropogenic sources within New Castle County. DNREC estimated anthropogenic emissions for nitrogen oxide (NO
Point sources are larger sources that are located at a fixed, stationary location. As defined by the AERR in 40 CFR 51.50, point sources are large, stationary (non-mobile), identifiable sources of emissions that release pollutants into the atmosphere. A point source is a facility that is a major source under 40 CFR part 70 for one or more of the pollutants for which reporting is required by 40 CFR 51.15(a)(1). These point sources can be associated with a single point or group of points in space. Examples of point source emissions categories include power plants, industrial boilers, petroleum refineries, cement plants, and other industrial plants.
As stated in Section 2 of the 2017 New Castle County BYE, point sources included large industrial (
DNREC's Division of Air Quality (DAQ) developed the point source data for the 2017 base year inventory. The point source inventory contains emissions for electric generating units (EGUs) and Non-EGU sources in the nonattainment area. EPA guidance for emissions inventory development provides that ozone season day emissions are used for the base year inventory for the nonattainment area. DAQ developed their 2017 inventory by using emissions directly reported to the agency by facilities as required by Delaware air quality regulations. These emissions are also reported to EPA, and after going through EPA's quality assurance (QA) and quality control (QC) process, are included in EPA's National Emissions Inventory (NEI). The emissions for this base year can be found in EPA's 2017 NEI.
Stationary non-point sources represent a large and diverse set of individual emission source categories. These sources collectively represent individual sources of emissions that have not been inventoried as either specific stationary point or mobile sources, and are typically too small, numerous, or difficult to inventory using the methods for the other classes of sources.
Stationary non-point sources that DNREC evaluated for the 2017 New Castle County BYE include solvent use (
Non-road mobile sources represent a large and diverse set of off-road vehicles and non-stationary equipment. As per 40 CFR 51.50, a non-road engine is an internal combustion engine (including the fuel system) that is not used in an on-road motor vehicle or a vehicle used solely for competition, or that is not affected by sections 111 or 202 of the CAA. Also defined by 40 CFR 51.50, a non-road vehicle (rather than engine) is a vehicle that is run by a non-road engine and that is not an on-road motor vehicle or a vehicle used solely for competition. Examples of non-road mobile sources include aircraft, airport ground support equipment, agricultural and construction equipment powered by an internal combustion engine, commercial marine vessels, locomotives, and lawn and garden engines and equipment.
As explained in Section 4 of the New Castle County BYE, consistent with EPA's Emission Inventory Guidance for Implementation of Ozone and Particulate Matter NAAQS and Regional Haze Regulations, DNREC used EPA's Motor Vehicle Emission Simulator (MOVES) 2014b model to develop the inventory for non-road mobile sources. MOVES2014 and later calculates emissions from both onroad and non-road mobile sources and covers non-road sources across 12 broad economic sectors (
Section 4 of the New Castle County BYE also includes aircraft, railroad locomotive, and commercial marine vessel emissions. DNREC calculated emissions from these sources by collecting data directly from surveyed sources, or activity from state and federal reporting agencies. To estimate emissions for aircraft, DNREC used airport activity statistics from the Federal Aviation Administration (FAA), landing and takeoff cycle information from the Delaware Department of Transportation (DelDOT), and survey information for landing and takeoffs, engine type, location, and usage data from airports within New Castle County. Railroad emission estimates were developed using activity and fuel consumption estimates collected from the rail companies within the state, including the Maryland & Delaware (MDDE) Railroad, Delaware Coast Line Railroad, Delmarva Central Railroad, Eastern Penn Railroad, and Wilmington and Western. For commercial marine vessels, DNREC calculated emissions for ocean-going vessels, towboats, tug-assist vessels, ferries, and vessels associated with dredging operations. Emissions were calculated based on mode of operation, vessel type, tonnage, and engine type; DNREC developed county emission allocation factors based on the location of the activity on various waterways and length of the waterway segment. These methods of calculating emissions are consistent with the most recent EPA emission inventory guidance.
On-road mobile sources are also called “highway mobile sources.” These sources are the motor vehicles (
As stated in Section 5 of the New Castle County BYE, DNREC used EPA's MOVES2014b model to estimate 2017 annual emissions and 2017 SSWD daily emissions from on-road sources in New Castle County. Emissions were estimated based on emission factors and vehicle activity. Emission factors for vehicles were based on vehicle type (
EPA has reviewed the results, procedures, and methodologies for the SIP base year, as well as comparing the inventory with previously QA/QC'd data in EPA's 2017 NEI for any data discrepancies and found none. EPA has therefore determined that the base year inventory to be acceptable and developed in accordance with EPA's technical guidance.
The New Castle County BYE contains a summary of 2017 annual and ozone SSWD daily emissions by source sector, which is presented in Table 1 in this document.
EPA's review of this material indicates the New Castle County base year inventory SIP meets the base year inventory requirement for the 2015 ozone NAAQS for Delaware's portion of the Philadelphia Area that is designated nonattainment, which consists of New Castle County, Delaware. Therefore, EPA is proposing to approve the New Castle County base year inventory SIP, which was submitted on October 9, 2020. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed rulemaking, proposing to approve Delaware's base year inventory SIP for the 2015 ozone NAAQS, does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the State, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS has received a request from the Sonoma County Water Agency (SCWA) for authorization to take marine mammals incidental to Russian River estuary management activities in Sonoma County, California, over the course of five years (2022-2027). As required by the Marine Mammal Protection Act (MMPA), NMFS is proposing regulations to govern that take and requests comments on the proposed regulations.
Comments and information must be received no later than February 22, 2022.
Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to
Ben Laws, Office of Protected Resources, NMFS, (301) 427-8401.
A copy of SCWA's application and any supporting documents, as well as a list of the references cited in this document, may be obtained online at:
We received an application from SCWA requesting 5-year regulations and authorization to take multiple species of marine mammals. This proposed rule would establish a framework under the authority of the MMPA (16 U.S.C. 1361
Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to five years if, after notice and public comment, the agency makes certain findings and issues regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the Proposed Mitigation section), as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I provide the legal basis for issuing this proposed rule containing five-year regulations, and for any subsequent LOAs. As directed by this legal authority, this proposed rule contains mitigation, monitoring, and reporting requirements.
Following is a summary of the major provisions of this proposed rule regarding SCWA's estuary management activities. These measures include:
• Measures to minimize the number and intensity of incidental takes during sensitive times of year and to minimize the duration of disturbances.
• Measures designed to eliminate startling reactions.
• Eliminating or altering management activities on the beach when pups are present, and by setting limits on the frequency and duration of events during pupping season.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). Further, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to as “mitigation”); and requirements pertaining to the mitigation, monitoring and reporting of the takings are set forth. The definitions of all applicable MMPA statutory terms cited above are included in the relevant sections below.
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the proposed action qualifies to be categorically excluded from further NEPA review.
Information in SCWA's application and this notice collectively provide the environmental information related to proposed issuance of these regulations and subsequent incidental take authorization for public review and comment. We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the request for incidental take authorization.
On September 2, 2021, we received an adequate and complete request from SCWA for authorization to take marine mammals incidental to estuary management activities. SCWA provided a final version of the application incorporating minor corrections on September 22, 2021. On September 29, 2021 (86 FR 53950), we published a notice of receipt of SCWA's application in the
SCWA proposes to manage the naturally-formed barrier beach at the mouth of the Russian River in order to minimize potential for flooding adjacent to the estuary and to enhance habitat for juvenile salmonids, as well as to conduct biological and physical monitoring of the barrier beach and estuary. Flood control-related breaching of the barrier beach at the mouth of the river may include artificial breaches, as well as construction and maintenance of a lagoon outlet channel. The latter activity, an alternative management technique conducted to mitigate impacts of flood control on rearing habitat for Endangered Species Act (ESA)-listed salmonids, occurs only from May 15 through October 15 (hereafter, the “lagoon management period”). Artificial breaching and monitoring activities may occur at any time during the period of validity of the proposed regulations. The requested regulations would be valid for 5 years, from April 21, 2022, through April 20, 2027.
Breaching of the naturally-formed barrier beach at the mouth of the Russian River requires the use of heavy equipment (
This request for incidental take regulations (ITR) and a subsequent Letter of Authorization (LOA) follows issuance of previous 5-year ITR (2017-2022) (82 FR 13765; March 15, 2017). Prior to issuance of that initial ITR, NMFS issued seven consecutive incidental harassment authorizations (IHA) to SCWA for incidental take associated with the same ongoing activities, between 2010-2016.
The proposed action involves management of the estuary to prevent flooding while preventing adverse modification to critical habitat for ESA-listed salmonids. Requirements related to the ESA are described in further detail below. During the lagoon management period, this involves construction and maintenance of a lagoon outlet channel that would facilitate formation of a perched lagoon. A perched lagoon, which is an estuary closed to tidal influence in which water surface elevation is above mean high tide, would reduce flooding while maintaining beneficial conditions for juvenile salmonids. Additional breaches of the barrier beach may be conducted for the sole purpose of reducing flood risk. SCWA's proposed activity was described in detail in our notice of proposed authorization prior to the 2011 IHA (76 FR 14924; March 18, 2011). SCWA's estuary management activities have not changed (aside from minor changes to SCWA's biological and physical estuary monitoring measures);
The specified activity may occur at any time during the five-year period of validity for these proposed regulations (2022-2027), although construction and maintenance of a lagoon outlet channel would occur only during the lagoon management period. In addition, there are certain restrictions placed on SCWA during the harbor seal pupping season. These, as well as periodicity and frequency of the specified activities, are described in further detail below.
The estuary is located about 97 kilometers (km) (60 miles (mi)) northwest of San Francisco in Sonoma County, near Jenner, California (see Figure 1 of SCWA's application). The Russian River watershed encompasses 3,847 km
Within the Russian River watershed, the U.S. Army Corps of Engineers (Corps), SCWA, and the Mendocino County Russian River Flood Control and Water Conservation Improvement District (District) operate and maintain Federal facilities and conduct activities in addition to the estuary management, including flood control, water diversion and storage, instream flow releases, hydroelectric power generation, channel maintenance, and fish hatchery production. The Corps, SCWA, and the District conducted these activities for many years before salmonid species in the Russian River were protected under the ESA. Upon determination that these actions were likely to affect ESA-listed salmonids, as well as designated critical habitat for these species, formal consultation under section 7 of the ESA was initiated. In 2008, NMFS issued a Biological Opinion (BiOp) for Water Supply, Flood Control Operations, and Channel Maintenance conducted by the Corps, SCWA, and the District in the Russian River watershed (NMFS, 2008). This BiOp found that the activities—including SCWA's estuary management activities—authorized by the Corps and undertaken by SCWA and the District, if continued in a manner similar to recent historic practices, were likely to jeopardize the continued existence of ESA-listed salmonids and were likely to adversely modify critical habitat.
If a project is found to jeopardize a species or adversely modify its critical habitat, NMFS must develop and recommend a non-jeopardizing Reasonable and Prudent Alternative (RPA) to the proposed project, in coordination with the federal action agency and any applicant. A component of the RPA described in the 2008 BiOp requires SCWA to collaborate with NMFS and modify their estuary water level management in order to reduce marine influence (
The analysis contained in the BiOp found that maintenance of lagoon conditions was necessary only for the lagoon management period. See NMFS' BiOp (2008) for details of that analysis. As a result of that determination, there are three components to SCWA's estuary management activities: (1) Lagoon outlet channel management, during the lagoon management period only, required to accomplish the dual purposes of flood risk abatement and maintenance of juvenile salmonid habitat; (2) traditional artificial breaching, with the sole goal of flood risk abatement; and (3) physical and biological monitoring. Monitoring is conducted to measure changes in the beach and channel elevation, lengths, and widths, as well as flow velocities and observations of the bed structure in the channel. SCWA is also required through the BiOp to collect biological, water quality, and physical habitat data in conjunction with estuary management. These monitoring activities include fisheries sampling, water quality monitoring, invertebrate sampling, and physical habitat measurements requiring the use of boats in the estuary. Please see the previously referenced
NMFS' BiOp determined that salmonid estuarine habitat may be improved by managing the Russian River estuary as a perched, freshwater lagoon and, therefore, stipulates as an RPA to existing conditions that the estuary be managed to achieve such conditions between May 15th and October 15th. In recognition of the complexity and uncertainty inherent in attempting to manage conditions in a dynamic beach environment, the BiOp stipulates that the estuarine water surface elevation RPA be managed adaptively, meaning that it should be planned, implemented, and then iteratively refined based on experience gained from implementation.
The estuary closes throughout the year as a result of a sandbar forming at the mouth of the Russian River. To facilitate summer lagoon management, SCWA would construct the lagoon outlet channel after the first natural barrier beach closure, but the lagoon would generally be managed during the lagoon management period. It is anticipated that the outlet channel implementation would be a 2-day event with initial construction of the lagoon outlet channel taking one day of work, and subsequent adjustments to the outlet channel on the second day. Subsequent maintenance would occur approximately weekly until the end of the lagoon management period. Artificial breaching activities would generally occur at any time of year outside the lagoon management period. Biological and physical habitat monitoring can occur at any time of year, but generally occurs from mid-April through December, with the exception of topographic beach surveys that occur year round.
Harbor seals are the most common species inhabiting the haul-out at the mouth of the Russian River (Jenner haul-out) and fine-scale local abundance data for harbor seals have been recorded extensively since 1972. California sea lions and northern elephant seals have also been observed infrequently in the project area. In addition to the primary Jenner haul-out, there are eight peripheral haul-outs nearby (see Figure 1 of SCWA's application). These include North Jenner and Odin Cove to the north; Pocked Rock, Kabemali, and Rock Point to the south; and Penny Logs, Patty's Rock, and Chalanchawi upstream within the estuary.
This section provides summary information regarding local occurrence of these species. We have reviewed SCWA's detailed species descriptions, including life history information, for accuracy and completeness and refer the
Harbor seals inhabit coastal and estuarine waters and shoreline areas of the Northern Hemisphere from temperate to polar regions. The eastern North Pacific subspecies is found from Baja California north to the Aleutian Islands and into the Bering Sea. Multiple lines of evidence support the existence of geographic structure among harbor seal populations from California to Alaska (Carretta
California harbor seals are not protected under the ESA or listed as depleted under the MMPA, and are not considered a strategic stock under the MMPA because annual human-caused mortality (43) is significantly less than the calculated potential biological removal (PBR; 1,641) (Carretta
Harbor seal pupping normally occurs at the Russian River beginning in March and continuing into May, and pups are counted during surveys through June, after which time it becomes difficult to distinguish pups from sub-adult seals. The Jenner haul-out is the largest in Sonoma County. A substantial amount of monitoring effort has been conducted at the Jenner haul-out and surrounding areas. Concerned local residents formed the Stewards' Seal Watch Public Education Program in 1985 to educate beach visitors and monitor seal populations. State Parks Volunteer Docents continue this effort towards safeguarding local harbor seal habitat. On weekends during the pupping and molting season (approximately March-August), volunteers conduct public outreach and record the numbers of visitors and seals on the beach, other marine mammals observed, and the number of boats and kayaks present.
Ongoing monthly seal counts at the Jenner haul-out were begun by J. Mortenson in January 1987, with additional nearby haul-outs added to the counts thereafter. In addition, local resident E. Twohy began daily observations of seals and people at the Jenner haul-out in November 1989. These datasets note whether the mouth at the Jenner haul-out was opened or closed at each observation, as well as various other daily and annual patterns of haul-out usage (Mortenson and Twohy, 1994). In 2009, SCWA began regular baseline monitoring of the haul-out as a component of its estuary management activity.
The number of harbor seals at the Russian River varies throughout the year, with peak seal abundance typically during the summer molting period (Figure 4). Abundance of seals on the Jenner haul-out declines in the fall after the molting season is complete, but seals are present at Jenner and locally year round. The number of harbor seals at this haul-out has fluctuated from year to year. See Figures 4 and 5 in SCWA's application for additional detail.
The number of seals present at the Jenner haul-out generally declines during bar-closed conditions (Mortenson, 1996). SCWA's pinniped monitoring efforts from 1996 to 2000 focused on artificial breaching activities and their effects on the Jenner haul-out. Seal counts and disturbances were recorded from one to two days prior to breaching, the day of breaching, and the day after breaching (MSC, 1997, 1998, 1999, 2000; SCWA and MSC, 2001). In each year, the trend observed was that harbor seal numbers generally declined during a beach closure and increased the day following an artificial breaching event. Heckel and McIver (1994) speculated that the loss of easy access to the haul-out and ready escape to the sea during bar-closed conditions may account for the lower numbers. SCWA's pinniped monitoring program since 2009 has included observations from water level management activities (
Mortenson (1996) observed that pups were first seen at the Jenner haul-out in late March, with maximum counts in May. In this study, pups were not counted separately from other age classes at the haul-out after August due to the difficulty in discriminating pups from small yearlings. From 1989 to 1991, Hanson (1993) observed that pupping began at the Jenner haul-out in mid-April, with a maximum number of pups observed during the first two weeks of May. This corresponds with the peaks observed at Point Reyes, where the first viable pups are born in March and the peak is the last week of April to early May (SCWA, 2014). Based on this information, pupping season at the Jenner haul-out is conservatively defined here as March 15 to June 30.
California sea lions range from the Gulf of California north to the Gulf of Alaska, with breeding areas located in the Gulf of California, western Baja California, and southern California. Five genetically distinct geographic populations have been identified: (1) Pacific Temperate, (2) Pacific Subtropical, (3) Southern Gulf of California, (4) Central Gulf of California and (5) Northern Gulf of California (Schramm
California sea lions are not protected under the ESA or listed as depleted under the MMPA. Total annual human-caused mortality (≥321) is substantially less than the PBR (estimated at 14,011); therefore, California sea lions are not considered a strategic stock under the MMPA. The best abundance estimate of the U.S. stock of California sea lions is 257,606 and the minimum population size of this stock is 233,515 individuals (Carretta
Solitary California sea lions have occasionally been observed at or in the vicinity of the Russian River estuary (MSC, 1999, 2000), in all months of the year except June. Male California sea lions are occasionally observed hauled out at or near the Russian River mouth in most years, including 2016-2018 and 2020. Other individuals were observed in the surf at the mouth of the river or swimming inside the estuary. Juvenile sea lions have also been observed during monitoring of peripheral haul-outs. The occurrence of individual California sea lions in the action area may occur year-round, but is infrequent and sporadic.
Northern elephant seals gather at breeding areas, located primarily on offshore islands of Baja California and California, from approximately December to March before dispersing for feeding. Males feed near the eastern Aleutian Islands and in the Gulf of Alaska, while females feed at sea south of 45° N (Stewart and Huber, 1993; Le Boeuf
Northern elephant seals are not protected under the ESA or listed as depleted under the MMPA. Total annual human-caused mortality (5.3) is substantially less than the PBR (estimated at 5,122); therefore, northern elephant seals are not considered a strategic stock under the MMPA. The best abundance estimate of the California breeding population of northern elephant seals is 187,386 and the minimum population size of this stock is 85,369 individuals (Carretta
Censuses of pinnipeds at the mouth of the Russian River have been taken at least semi-monthly since 1987. Elephant seals were noted from 1987-95, with one or two elephant seals typically counted during May censuses, and occasional records during the fall and winter (Mortenson and Follis, 1997). A single, tagged northern elephant seal sub-adult was present at the Jenner haul-out from 2002-07. This individual seal, which was observed harassing harbor seals also present at the haul-out, was generally present during molt and again from late December through March. In recent years individual sub-adult elephant seals have been observed on a few occasions hauled out at the Russian River in the late summer and early fall. The occurrence of individual northern elephant seals in the action area has generally been infrequent and sporadic.
This section includes a summary and discussion of the ways that components of the specified activity may impact marine mammals and their habitat. The Estimated Take section later in this document will include a quantitative analysis of the number of incidents of take expected to occur incidental to this activity. The Negligible Impact Analysis and Determination section will include an analysis of how this specific activity will impact marine mammals and will consider the content of this section, the Estimated Take section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and from that on the affected marine mammal populations or stocks.
A significant body of monitoring data exists for pinnipeds at the mouth of the Russian River. In addition, pinnipeds have co-existed with regular estuary management activity for decades, as well as with regular human use activity at the beach, and are likely habituated to human presence and activity. Nevertheless, SCWA's estuary management activities have the potential to disturb pinnipeds present on the beach or at peripheral haul-outs in the estuary. During breaching operations, past monitoring has revealed that some or all of the seals present typically move or flush from the beach in response to the presence of crew and equipment, though some may remain hauled-out. No stampeding of seals—a potentially dangerous occurrence in which large numbers of animals succumb to mass panic and rush away from a stimulus—has been documented since SCWA developed protocols to prevent such events in 1999. While it is likely impossible to conduct required estuary management activities without provoking some response in hauled-out animals, precautionary mitigation measures, described later in this document, ensure that animals are gradually apprised of human approach. Under these conditions, seals typically exhibit a continuum of responses, beginning with alert movements (
In the absence of appropriate mitigation measures, it is possible that pinnipeds could be subject to injury, serious injury, or mortality, likely through stampeding or abandonment of pups. However, based on a significant body of site-specific data, harbor seals are unlikely to sustain any harassment that may be considered biologically significant. Individual animals would, at most, flush into the water in response to maintenance activities but may also simply become alert or move across the beach away from equipment and crews. SCWA has observed that harbor seals are generally less likely to flush from the beach when the primary aggregation of seals is north of the breaching activity (please refer to Figure 2 of SCWA's application), meaning that personnel and equipment are not required to pass the seals.
California sea lions and northern elephant seals have been observed as less sensitive to stimulus than harbor seals during monitoring at numerous other sites. For example, monitoring of pinniped disturbance as a result of abalone research in the Channel Islands showed that while harbor seals flushed at a rate of 69 percent, California sea lions flushed at a rate of only 21 percent. The rate for elephant seals declined to 0.1 percent (VanBlaricom, 2010). In the event that either of these species is present during management activities, they would be expected to display a minimal reaction to maintenance activities—less than that expected of harbor seals.
Although the Jenner haul-out is not known as a primary pupping beach,
Similarly, the period of mother-pup bonding, critical time needed to ensure pup survival and maximize pup health, is not expected to be impacted by estuary management activities. Harbor seal pups are extremely precocious, swimming and diving immediately after birth and throughout the lactation period, unlike most other phocids which normally enter the sea only after weaning (Lawson and Renouf, 1985; Cottrell
In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (
The purposes of the estuary management activities are to improve summer rearing habitat for juvenile salmonids in the Russian River estuary and/or to minimize potential flood risk to properties adjacent to the estuary. These activities would result in temporary physical alteration of the Jenner haul-out, but are essential to conserving and recovering endangered salmonid species, as prescribed by the BiOp. These salmonids are themselves prey for pinnipeds. In addition, with barrier beach closure, seal usage of the beach haul-out declines, and the three nearby river haul-outs may not be available for usage due to rising water surface elevations. Breaching of the barrier beach, subsequent to the temporary habitat disturbance, likely increases suitability and availability of habitat for pinnipeds. Biological and water quality monitoring would not physically alter pinniped habitat. Please see the previously referenced
During SCWA's pinniped monitoring associated with artificial breaching activities from 1996 to 2000, the number of harbor seals hauled out declined when the barrier beach closed and then increased the day following an artificial breaching event (MSC, 1997, 1998, 1999, and 2000; SCWA and MSC, 2001). This response to barrier beach closure followed by artificial breaching has remained consistent in recent years and is anticipated to continue. However, it is possible that the number of pinnipeds using the haul-out could decline during the extended lagoon management period, when SCWA would seek to maintain a shallow outlet channel rather than the deeper channel associated with artificial breaching. Collection of baseline information during the lagoon management period is included in the monitoring requirements described later in this document. SCWA's previous monitoring indicates that the number of seals at the haul-out declines from August to October, so management of the lagoon outlet channel (and managing the sandbar as a summer lagoon) would have little effect on haul-out use during the latter portion of the lagoon management period. The early portion of the lagoon management period coincides with the pupping season. Past monitoring during this period, which represents some of the longest beach closures in the late spring and early summer months, shows that the number of pinnipeds at the haul-out tends to fluctuate, rather than showing the more straightforward declines and increases associated with closures and openings seen at other times of year (MSC, 1998). This may indicate that seal haul-out usage during the pupping season is less dependent on bar status. As such, the number of seals hauled out from May through July would be expected to fluctuate but is unlikely to respond dramatically to the absence of artificial breaching events. Regardless, any impacts to habitat resulting from SCWA's management of the estuary during the lagoon management period are not in relation to natural conditions but, rather, in relation to conditions resulting from SCWA's discontinued approach of artificial breaching during this period.
In summary, there will be temporary physical alteration of the beach. However, natural opening and closure of the beach results in the same impacts to habitat. Therefore, seals are likely adapted to this cycle. In addition, the increase in rearing habitat quality has the goal of increasing salmonid abundance, ultimately providing more food for seals present within the action area. Thus, any impacts to marine mammal habitat are not expected to cause significant or long-term consequences for individual marine mammals or their populations.
This section provides an estimate of the number of incidental takes proposed for authorization, which will inform both NMFS's consideration of whether the number of takes is “small” and the negligible impact determination.
Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as: Any act of pursuit, torment, or annoyance which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
SCWA has requested, and NMFS proposes, authorization to take harbor seals, California sea lions, and northern
Events associated with lagoon outlet channel management would occur only during the lagoon management period and are split into two categories: (1) Initial channel implementation, which would likely occur between May and September; and (2) maintenance and monitoring of the outlet channel, which would continue until October 15. In addition, it is possible that the initial outlet channel could close through natural processes, requiring additional channel implementation events. Based on past experience, SCWA estimates that a maximum of three outlet channel implementation events could be required, with each event lasting up to two days. Outlet channel implementation events would only occur when the bar is closed. Therefore, it is appropriate to use data from bar-closed monitoring events in estimating take (Table 2). Construction of the outlet channel is designed to produce a perched outflow, resulting in conditions that more closely resemble bar-closed than bar-open with regard to pinniped haul-out usage. As such, bar-closed data is appropriate for estimating take during all lagoon management period maintenance and monitoring activity. As dates of outlet channel implementation cannot be known in advance, the highest daily average of seals per month during the lagoon management period—the May average for 2010-20—is used in estimating take. For maintenance and monitoring activities associated with the lagoon outlet channel, which would occur on a weekly basis following implementation of the outlet channel, the average number of harbor seals for each month during bar-closed conditions was used.
Artificial breaching activities would also occur during bar-closed conditions, and the average number of harbor seals for each month during bar-closed conditions was used (Table 2). The number of estimated artificial breaching events is informed by experience. For those months with more frequent historical bar closure events, we assume that two such events could occur in any given year. For other months, we assume that only one such event would occur in a given year. The average total number of events from 2000-2020 is 5 per year, meaning that the estimated take numbers for artificial breaching are conservative. Please see Table 1 in SCWA's application for more information.
For monthly topographic surveys on the barrier beach, potential incidental take of harbor seals is typically calculated as one hundred percent of the seals expected to be encountered. The exception is during the month of April, when surveyors would avoid seals to reduce harassment of pups and/or mothers with neonates. For the monthly topographic survey during April, surveyors would not approach or retreat slowly away from the haul-out when neonates are present, typically resulting in no disturbance. For that survey, the assumption is therefore that only ten percent of seals present would be harassed. The number of seals expected to be encountered is based on the overall average monthly number of seals hauled out as recorded during baseline surveys conducted by SCWA in 2010-20 (Table 2).
For biological and physical habitat monitoring activities in the estuary, it was assumed that pinnipeds may be encountered once per event and flush from a river haul-out. The potential for harassment associated with these events is limited to the peripheral haul-outs located in the estuary. In past experience, SCWA typically sees no more than a single harbor seal at these haul-outs, which consist of scattered logs and rocks that often submerge at high tide.
As described previously, California sea lions and northern elephant seals are occasional visitors to the estuary. Based on limited information regarding occurrence of these species at the mouth of the Russian River estuary, we assume there is the potential to encounter one animal of each species per month throughout the year. Lagoon outlet channel activities could potentially occur over six months of the year, artificial breaching activities over eight months, topographic surveys year-round, and biological and physical monitoring in the estuary over eight months. Therefore, we assume that up to 34 incidents of take could occur per year for both the California sea lion and northern elephant seal. Based on past occurrence records, the proposed take authorization for these two species is likely a precautionary overestimate.
The take numbers described in the preceding text are annual estimates. Therefore, over the course of the 5-year period of validity of the proposed regulations, we propose to authorize through Letter of Authorization a total of 27,585 incidents of take for harbor seals and 170 such incidents each for the California sea lion and northern elephant seal.
Under Section 101(a)(5)(A) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to such activity, and other means of effecting the least practicable adverse impact on such species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for taking for certain subsistence uses (“least practicable adverse impact”). NMFS does not have a regulatory definition for “least practicable adverse impact.” However, NMFS' implementing regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, we carefully consider two primary factors:
(1) The manner in which, and the degree to which, implementation of the measure(s) is expected to reduce impacts to marine mammal species or stocks, their habitat, and their availability for subsistence uses. This analysis will consider such things as the nature of the potential adverse impact (such as likelihood, scope, and range), the likelihood that the measure will be effective if implemented, and the likelihood of successful implementation.
(2) The practicability of the measure for applicant implementation. Practicability of implementation may consider such things as cost, impact on operations, personnel safety, and practicality of implementation.
SCWA has proposed to continue the following mitigation measures, as implemented during the previous ITAs, designed to minimize impact to affected species and stocks:
• SCWA crews would cautiously approach (
• SCWA staff would avoid walking or driving equipment through the seal haul-out.
• Crews on foot would make an effort to be seen by seals from a distance, if possible, rather than appearing suddenly, again preventing sudden flushes.
• Equipment would be driven slowly on the beach and care would be taken to minimize the number of shut-downs and start-ups when the equipment is on the beach to reduce disturbance of seals from loud noises following a relatively quiet period.
In addition, SCWA proposes to continue mitigation measures specific to pupping season (March 15-June 30), as implemented in the previous ITAs:
• SCWA will maintain a one week no-work period between water level management events (unless flooding is an immediate threat) to allow for an adequate disturbance recovery period. During the no-work period, equipment must be removed from the beach.
• A water level management event may not occur for more than two consecutive days unless flooding threats cannot be controlled.
• If a pup less than one week old is on the beach where heavy machinery would be used or on the path used to access the work location, the management action will be delayed until the pup has left the site or the latest day possible to prevent flooding while still maintaining suitable fish rearing habitat. In the event that a pup remains present on the beach in the presence of flood risk, SCWA would consult with NMFS to determine the appropriate course of action. SCWA will coordinate with the locally established seal monitoring program (Stewards' Seal Watch) to determine if pups less than one week old are on the beach prior to a breaching event.
• Physical and biological monitoring will not be conducted if a pup less than one week old is present at the monitoring site or on a path to the site.
For all activities, personnel on the beach would include equipment operators and safety team members. Occasionally, there would be additional people (SCWA staff or regulatory agency staff) on the beach to observe the activities. SCWA staff would be followed by the equipment, which would then be followed by an SCWA vehicle (typically a small pickup truck, the vehicle would be parked at the previously posted signs and barriers on the south side of the excavation location). Equipment would be driven slowly on the beach and care would be taken to minimize the number of shut-downs and start-ups when the equipment is on the beach. All work would be completed as efficiently as possible, with the smallest amount of heavy equipment possible, to minimize disturbance of seals at the haul-out. Boats operating near river haul-outs during monitoring would be kept within posted speed limits and driven as far from the haul-outs as safely possible to minimize flushing seals.
We have carefully evaluated SCWA's proposed mitigation measures and considered a range of other measures in the context of ensuring that we prescribed the means of effecting the least practicable adverse impact on the affected marine mammal species and stocks and their habitat. Based on our evaluation of these measures, we have preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable adverse impact on marine mammal species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of such species or stock for subsistence uses.
In order to issue an LOA for an activity, Section 101(a)(5)(A) of the MMPA states that NMFS must set forth requirements pertaining to the monitoring and reporting of the authorized taking. NMFS's MMPA implementing regulations further describe the information that an applicant should provide when requesting an authorization (50 CFR 216.104(a)(13)), including the means of accomplishing the necessary monitoring and reporting that will result in increased knowledge of the species and the level of taking or impacts on populations of marine mammals.
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of significant interactions with marine mammal species in action area (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) Action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors.
• How anticipated responses to stressors impact either: (1) Long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks.
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
SCWA submitted a marine mammal monitoring plan as part of the ITA application. It can be found online at
Baseline monitoring will occur at the Jenner overlook from March 15 to October 15. This schedule would capture the pupping and molting seasons, and extend to the end of the beach management period, when management activities are more likely to occur. Surveys would be conducted twice monthly, except for the pupping season (April-May) when surveys would be conducted weekly in order to record the presence of neonate harbor seals. The haul-out will be monitored for 4 hours, scheduled for any consecutive block between the hours of 0800 and 1600. An effort will be made to avoid periods of high tide when scheduling baseline surveys.
All seals hauled out on the beach will be counted every 30 minutes from the overlook on the bluff along Highway 1 adjacent to the haul-out using a high powered spotting scope. Monitoring may conclude for the day if weather conditions affect visibility (
In addition to the count data, disturbances of the haul-out will be recorded. The methods for recording disturbances would follow a three-point scale adopted by NMFS that represents an increasing seal response to the disturbance (Table 4). For each disturbance event the disturbance source and seal response will be recorded and tallied. Disturbance events corresponding with Levels 2-3 are considered to be harassment. Weather conditions will also be recorded at the beginning of each survey.
A 1-day pre-outlet channel survey would be made within 1 to 3 days prior to constructing the outlet channel. The haul-out would be monitored on the day the outlet channel is constructed and daily for up to 2 days during channel excavation activities. Monitoring would also occur on each day that the outlet channel is maintained using heavy equipment for the duration of the lagoon management period.
Monitoring of outlet channel maintenance would correspond with the monitoring described under the “Baseline Monitoring” section above. Methods would follow the count and disturbance monitoring protocols described in the “Baseline Monitoring” section.
Pinniped response to artificial breaching will be monitored at each such event during the period of validity of these proposed regulations. Methods would follow the census and disturbance monitoring protocols described in the “Baseline Monitoring” section, which were also used for the 1996 to 2000 monitoring events and since 2009. The exception, as for lagoon management events, is that duration of monitoring is dependent upon duration of the event. On the day of the management event, pinniped monitoring begins at least one hour prior to the crew and equipment accessing the beach work area and continues through the duration of the event, until at least one hour after the crew and equipment leave the beach.
For all counts, the following information would be recorded in 30-minute intervals: (1) Pinniped counts, by species; (2) behavior; (3) time, source and duration of any disturbance; (4)
If, during monitoring, observers sight any pup that might be abandoned, SCWA would contact the NMFS stranding response network immediately and also report the incident to NMFS' West Coast Regional Office and Office of Protected Resources within 48 hours. Observers will not approach or move the pup. Potential indications that a pup may be abandoned are no observed contact with adult seals, no movement of the pup, and the pup's attempts to nurse are rebuffed.
Generally, volunteers would collect baseline data on Jenner haul-out use during the bi-weekly monitoring events. A schedule for this monitoring would be established with Stewards once volunteers are available for the monitoring effort. SCWA staff would monitor lagoon outlet channel excavation, maintenance activities, artificial breaching events, and biological or physical monitoring activities at the Jenner haul-out.
SCWA is required to submit an annual report on all activities and marine mammal monitoring results to NMFS within 90 days following the end of the monitoring period. These reports would contain the following information:
• The number of pinnipeds taken, by species and age class (if possible);
• Behavior prior to and during water level management events;
• Start and end time of activity;
• Estimated distances between source and pinnipeds when disturbance occurs;
• Weather conditions (
• Haul-out reoccupation time of any pinnipeds based on post-activity monitoring;
• Tide levels and estuary water surface elevation; and
• Pinniped census from bi-monthly and nearby haul-out monitoring.
The annual report includes descriptions of monitoring methodology, tabulation of estuary management events, summary of monitoring results, and discussion of problems noted and proposed remedial measures.
SCWA complied with the mitigation and monitoring required under previous authorizations. Previous monitoring reports are available online at
While the observed take in all years was significantly lower than the level authorized, it is possible that incidental take in future years could approach the level authorized. Actual take is dependent largely upon the number of water level management events that occur, which is unpredictable. Take of species other than harbor seals depends upon whether those species, which do not consistently utilize the Jenner haul-out, are present. The authorized take, though much higher than the actual take, is justified based on conservative estimated scenarios for animal presence and necessity of water level management. No significant departure from the method of estimation is used for these proposed regulations (see Estimated Take) for the same activities in 2022-27.
Since 2009 SCWA has been conducting baseline monitoring of the Jenner haul-out and several nearby coastal and estuary sites (as described in the 2016 Monitoring Plan, available online at
In addition to baseline monitoring, monitoring during water level management activities (breaching and lagoon outlet implementation) has been ongoing since 2009. Recent observations of seals during breaching activities indicate that seals leave the Jenner haul-out as safety crews approach their haul-out ahead of equipment. Depending on the location of their haul-out seals have also remained on the beach during breaching activities. The number of harbor seals hauled out at the mouth of the estuary declined when the barrier beach was closed and increased soon after it was breached. Seals that left the haul-out just prior to breaching have returned to the beach within hours of completion of activities and typically return prior to the next morning (see prior SCWA monitoring reports, available online at
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on
Although SCWA's estuary management activities may disturb pinnipeds hauled out at the mouth of the Russian River, as well as those hauled out at several locations in the estuary during recurring monitoring activities, impacts are occurring to a small, localized group of animals. While these impacts can occur year-round, they occur sporadically and for limited duration (
No injury, serious injury, or mortality is anticipated, nor is the proposed action likely to result in long-term impacts such as permanent abandonment of the haul-out. Injury, serious injury, or mortality to pinnipeds would likely result from startling animals inhabiting the haul-out into a stampede reaction, or from extended mother-pup separation as a result of such a stampede. Long-term impacts to pinniped usage of the haul-out were previously considered to be a potential result of increased presence of humans and equipment on the beach. However, 10 years of monitoring has not shown any such impacts to seal usage of the beach. Nevertheless, SCWA will continue to implement the previously described mitigation measures. These are designed to reduce the possibility of startling pinnipeds, by gradually apprising them of the presence of humans and equipment on the beach, and to reduce the possibility of impacts to pups by eliminating or altering management activities on the beach when pups are present and by setting limits on the frequency and duration of events during pupping season. During the past 20 years of flood control management, implementation of similar mitigation measures has resulted in no known stampede events and no known injury, serious injury, or mortality. Over the course of that time period, management events have generally been infrequent and of limited duration.
No pinniped stocks for which incidental take authorization is proposed are listed as threatened or endangered under the ESA or determined to be strategic or depleted under the MMPA. Existing data suggest that harbor seal populations have reached carrying capacity; populations of California sea lions and northern elephant seals in California are also considered healthy.
In summary, and based on extensive monitoring data, we believe that impacts to hauled-out pinnipeds during estuary management activities would be behavioral harassment of limited duration (
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, we preliminarily find that the total marine mammal take from SCWA's construction activities will have a negligible impact on the affected marine mammal species or stocks.
As noted above, only small numbers of incidental take may be authorized under section 101(a)(5)(A) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be taken is fewer than one third of the species or stock abundance, the take is considered to be of small numbers. Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
The annual amount of take NMFS proposes to authorize is below one-third of the estimated stock abundance for all species (see Table 3). However, this represents an overestimate of the number of individuals harassed annually over the duration of the proposed regulations, because these totals represent much smaller numbers of individuals that may be harassed multiple times. Based on the analysis contained herein of the proposed activity (including the proposed mitigation and monitoring measures) and the anticipated take of marine mammals, NMFS preliminarily finds that small numbers of marine mammals will be taken relative to the population size of the affected species or stocks.
There are no relevant subsistence uses of marine mammals implicated by the specified activity. Therefore, we have determined that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
The regulations governing the take of marine mammals incidental to SCWA estuary management activities would contain an adaptive management component.
The reporting requirements associated with this proposed rule are designed to provide NMFS with monitoring data from the previous year to allow consideration of whether any changes are appropriate. The use of adaptive management allows NMFS to consider new information from different sources
SCWA's monitoring program (see Proposed Monitoring) would be managed adaptively. Changes to the proposed monitoring program may be adopted if they are reasonably likely to better accomplish the MMPA monitoring goals described previously or may better answer the specific questions associated with SCWA's monitoring plan.
The following are some of the possible sources of applicable data to be considered through the adaptive management process: (1) Results from monitoring reports, as required by MMPA authorizations; (2) results from general marine mammal and sound research; and (3) any information which reveals that marine mammals may have been taken in a manner, extent, or number not authorized by these regulations or subsequent LOAs.
No marine mammal species listed under the ESA are expected to be affected by these activities. Therefore, we have determined that section 7 consultation under the ESA is not required.
NMFS requests interested persons to submit comments, information, and suggestions concerning SCWA's request and the proposed regulations (see
Pursuant to the procedures established to implement Executive Order 12866, the Office of Management and Budget has determined that this proposed rule is not significant.
Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), the Chief Counsel for Regulation of the Department of Commerce has certified to the Chief Counsel for Advocacy of the Small Business Administration that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. SCWA is the sole entity that would be subject to the requirements in these proposed regulations, and the Sonoma County Water Agency is not a small governmental jurisdiction, small organization, or small business, as defined by the RFA. Under the RFA, governmental jurisdictions are considered to be small if they are “. . . governments of cities, counties, towns, townships, villages, school districts, or special districts, with a population of less than 50,000. . . .” As of the 2020 census, Sonoma County, CA had a population of nearly 500,000 people. Because of this certification, a regulatory flexibility analysis is not required and none has been prepared.
Notwithstanding any other provision of law, no person is required to respond to nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act (PRA) unless that collection of information displays a currently valid OMB control number. These requirements have been approved by OMB under control number 0648-0151 and include applications for regulations, subsequent LOAs, and reports. Send comments regarding any aspect of this data collection, including suggestions for reducing the burden, to NMFS.
Exports, Fish, Imports, Indians, Labeling, Marine mammals, Penalties, Reporting and recordkeeping requirements, Seafood, Transportation.
For reasons set forth in the preamble, 50 CFR part 217 is proposed to be amended as follows:
16 U.S.C. 1361
(a) Regulations in this subpart apply only to the Sonoma County Water Agency (SCWA) and those persons it authorizes or funds to conduct activities on its behalf for the taking of marine mammals that occurs in the area outlined in paragraph (b) of this section and that occurs incidental to estuary management activities.
(b) The taking of marine mammals by SCWA may be authorized in a Letter of Authorization (LOA) only if it occurs at Goat Rock State Beach or in the Russian River estuary in California.
Regulations in this subpart are effective from April 21, 2022, through April 20, 2027.
(a) Under LOAs issued pursuant to §§ 216.106 of this chapter and 217.7, the Holder of the LOA (hereinafter “SCWA”) may incidentally, but not intentionally, take marine mammals within the area described in § 217.1(b) of this chapter by Level B harassment associated with estuary management activities, provided the activity is in compliance with all terms, conditions, and requirements of the regulations in this subpart and the appropriate LOA.
(b) [Reserved]
Except for the takings contemplated in § 217.3 and authorized by an LOA issued under §§ 216.106 of this chapter and 217.7, it is unlawful for any person to do any of the following in connection with the activities described in § 217.1 of this chapter:
(a) Violate, or fail to comply with, the terms, conditions, and requirements of this subpart or an LOA issued under §§ 216.106 of this chapter and 217.7;
(b) Take any marine mammal not specified in such LOAs;
(c) Take any marine mammal specified in such LOAs in any manner other than as specified;
(d) Take a marine mammal specified in such LOAs if NMFS determines such taking results in more than a negligible impact on the species or stocks of such marine mammal; or
(e) Take a marine mammal specified in such LOAs if NMFS determines such taking results in an unmitigable adverse impact on the species or stock of such marine mammal for taking for subsistence uses.
When conducting the activities identified in § 217.1(a), the mitigation measures contained in any LOA issued under §§ 216.106 of this chapter and 217.7 must be implemented. These mitigation measures shall include but are not limited to:
(a) General conditions:
(1) A copy of any issued LOA must be in the possession of SCWA, its designees, and work crew personnel operating under the authority of the issued LOA.
(2) If SCWA observes a pup that may be abandoned, it shall contact the National Marine Fisheries Service (NMFS) West Coast Regional Stranding Coordinator immediately and also report the incident to NMFS Office of Protected Resources within 48 hours. Observers shall not approach or move the pup.
(b) SCWA crews shall cautiously approach the haul-out ahead of heavy equipment.
(c) SCWA staff shall avoid walking or driving equipment through the seal haul-out.
(d) Crews on foot shall make an effort to be seen by seals from a distance.
(e) All work shall be completed as efficiently as possible and with the smallest amount of heavy equipment possible.
(f) Boats operating near river haul-outs during monitoring shall be kept within posted speed limits and driven as far from the haul-outs as safely possible.
(g) SCWA shall implement the following mitigation measures during pupping season (March 15-June 30):
(1) SCWA shall maintain a one week no-work period between water level management events (unless flooding is an immediate threat) to allow for an adequate disturbance recovery period. During the no-work period, equipment must be removed from the beach;
(2) A water level management event may not occur for more than two consecutive days unless flooding threats cannot be controlled.
(3) If a pup less than one week old is on the beach where heavy machinery will be used or on the path used to access the work location, the management action shall be delayed until the pup has left the site or the latest day possible to prevent flooding while still maintaining suitable fish rearing habitat. In the event that a pup remains present on the beach in the presence of flood risk, SCWA shall consult with NMFS and the California Department of Fish and Wildlife to determine the appropriate course of action. SCWA shall determine if pups less than one week old are on the beach prior to a breaching event.
(4) Physical and biological monitoring shall not be conducted if a pup less than one week old is present at the monitoring site or on a path to the site.
(a) Monitoring and reporting shall be conducted in accordance with the approved Pinniped Monitoring Plan.
(b) Reporting:
(1) Annual reporting:
(i) SCWA shall submit an annual summary report to NMFS not later than ninety days following the end of a given calendar year. SCWA shall provide a final report within thirty days following resolution of comments on the draft report.
(ii) These reports shall contain, at minimum, the following:
(A) The number of seals taken, by species and age class (if possible);
(B) Behavior prior to and during water level management events;
(C) Start and end time of activity;
(D) Estimated distances between source and seals when disturbance occurs;
(E) Weather conditions (
(F) Haul-out reoccupation time of any seals based on post-activity monitoring;
(G) Tide levels and estuary water surface elevation; and
(H) Seal census from haul-out monitoring.
(2) [Reserved]
(c) Reporting of injured or dead marine mammals:
(1) In the unanticipated event that the activity defined in § 217.1(a) clearly causes the take of a marine mammal in a prohibited manner, SCWA shall immediately cease such activity and report the incident to the Office of Protected Resources (OPR), NMFS and the West Coast Regional Stranding Coordinator, NMFS. Activities shall not resume until NMFS is able to review the circumstances of the prohibited take. NMFS will work with SCWA to determine what measures are necessary to minimize the likelihood of further prohibited take and ensure MMPA compliance. SCWA may not resume their activities until notified by NMFS. The report must include the following information:
(i) Time and date of the incident;
(ii) Description of the incident;
(iii) Environmental conditions;
(iv) Description of all marine mammal observations in the 24 hours preceding the incident;
(v) Species identification or description of the animal(s) involved;
(vi) Fate of the animal(s); and
(vii) Photographs or video footage of the animal(s).
(2) In the event that SCWA discovers an injured or dead marine mammal and determines that the cause of the injury or death is unknown and the death is relatively recent (
(3) In the event that SCWA discovers an injured or dead marine mammal and determines that the injury or death is not associated with or related to the activities defined in § 217.1(a) (
(4) Pursuant to paragraphs (c)(2-3) of this section, SCWA may use discretion in determining what injuries (
(a) To incidentally take marine mammals pursuant to these regulations, SCWA must apply for and obtain an LOA.
(b) An LOA, unless suspended or revoked, may be effective for a period of time not to exceed the expiration date of these regulations.
(c) If an LOA expires prior to the expiration date of these regulations,
(d) In the event of projected changes to the activity or to mitigation and monitoring measures required by an LOA, SCWA must apply for and obtain a modification of the LOA as described in § 217.8.
(e) The LOA shall set forth:
(1) Permissible methods of incidental taking;
(2) Means of effecting the least practicable adverse impact (
(3) Requirements for monitoring and reporting.
(f) Issuance of the LOA shall be based on a determination that the level of taking will be consistent with the findings made for the total taking allowable under these regulations.
(g) Notice of issuance or denial of an LOA shall be published in the
(a) An LOA issued under §§ 216.106 of this chapter and 217.7 for the activity identified in § 217.1(a) shall be renewed or modified upon request by the applicant, provided that:
(1) The proposed specified activity and mitigation, monitoring, and reporting measures, as well as the anticipated impacts, are the same as those described and analyzed for these regulations (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section), and
(2) NMFS determines that the mitigation, monitoring, and reporting measures required by the previous LOA under these regulations were implemented.
(b) For an LOA modification or renewal requests by the applicant that include changes to the activity or the mitigation, monitoring, or reporting (excluding changes made pursuant to the adaptive management provision in paragraph (c)(1) of this section) that do not change the findings made for the regulations or result in no more than a minor change in the total estimated number of takes (or distribution by species or years), NMFS may publish a notice of proposed LOA in the
(c) An LOA issued under §§ 216.106 of this chapter and 217.7 for the activity identified in § 217.1(a) may be modified by NMFS under the following circumstances:
(1) Adaptive Management—NMFS may modify (including augment) the existing mitigation, monitoring, or reporting measures (after consulting with SCWA regarding the practicability of the modifications) if doing so creates a reasonable likelihood of more effectively accomplishing the goals of the mitigation and monitoring set forth in the preamble for these regulations.
(i) Possible sources of data that could contribute to the decision to modify the mitigation, monitoring, or reporting measures in an LOA:
(A) Results from SCWA's monitoring from the previous year(s).
(B) Results from other marine mammal and/or sound research or studies.
(C) Any information that reveals marine mammals may have been taken in a manner, extent or number not authorized by these regulations or subsequent LOAs.
(ii) If, through adaptive management, the modifications to the mitigation, monitoring, or reporting measures are substantial, NMFS will publish a notice of proposed LOA in the
(2) Emergencies—If NMFS determines that an emergency exists that poses a significant risk to the well-being of the species or stocks of marine mammals specified in LOAs issued pursuant to §§ 216.106 of this chapter and 217.7, an LOA may be modified without prior notice or opportunity for public comment. Notice would be published in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Announcement of availability of fishery ecosystem plan amendment; request for comments.
NMFS announces that the Western Pacific Fishery Management Council (Council) proposes to amend the Fishery Ecosystem Plan for the American Samoa Archipelago (FEP). If approved, Amendment 5 would establish a rebuilding plan for the American Samoa bottomfish stock complex. The Council recommended Amendment 5 to rebuild the bottomfish stock, which is overfished and experiencing overfishing.
NMFS must receive comments on Amendment 5 by March 22, 2022.
You may submit comments on this document, identified by NOAA-NMFS-2022-0006, by either of the following methods:
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•
•
Amendment 5 includes a draft environmental assessment (EA) and regulatory impact review (RIR) that analyzes the potential impacts of the proposed action and alternatives considered. Copies of Amendment 5, including the EA and RIR, and other supporting documents, are available at
Heather Cronin, Sustainable Fisheries, NMFS PIR, 808-725-5179.
NMFS and the Council manage the American Samoa bottomfish fishery under the FEP and implementing regulations. The Council and NMFS only have the authority to develop and implement fishery management regulations in Federal waters, and the American Samoa Government has the authority to implement fishery management measures in territorial waters. The fishery primarily targets and harvests 11 species of emperors, snappers, groupers, and jacks. Bottomfish are typically harvested in deep waters, though some species are caught over reefs at shallower depths. Fishing for bottomfish primarily occurs within 20 miles from shore using aluminum catamarans less than 32 feet (9.7 m) long, known locally as alia. There are fewer than 20 participants in the fishery. Bottomfish fishermen in American Samoa are not required to obtain a Federal permit to fish for bottomfish management unit species (BMUS) or report their BMUS catch to NMFS. American Samoa has a mandatory requirement for entities that sell any seafood products (
Currently, the fishery is relatively small and primarily non-commercial, but it is still of importance to the local economy, and from social, cultural, and food security standpoints. In the past 20 years, the estimated total catch has varied from a high of 42,301 lb (19,187 kg) in 2001 to a low of 7,688 lb (3,487 kg) in 2012. The average catch from 2018-2020 was 12,687 lb (5,755 kg), with 965 lb (438 kg) attributed to the commercial fishery and the 11,722 lb (5,317 kg) attributed to the non-commercial sector. In 2020, the commercial price was $3.48/lb ($7.67/kg) and the estimated fishery revenue was $4,018.
On February 10, 2020, NMFS notified the Council that the bottomfish stock complex was overfished and subject to overfishing (85 FR 26940, May 6, 2020). Consistent with section 304(e) of the Magnuson-Stevens Fishery Conservation and Management Act and implementing regulations at 50 CFR 600.310(j), the Council must prepare, and NMFS must implement a rebuilding plan within two years of the notification. If approved, Amendment 5 would implement a rebuilding plan for the American Samoa bottomfish stock complex that consists of an annual catch limit (ACL) and two accountability measures (AM). We would set the ACL to 5,000 lb (2,268 kg) starting in 2022. Because NMFS is obligated to manage the stock throughout its range, and the complex exists in both territorial and Federal waters, we would count harvests from territorial and Federal waters toward the ACL. Note, however, that existing data collection programs do not differentiate catch from territorial versus Federal waters. The fishing year is the calendar year.
As an in-season AM, if NMFS projects that the fishery will reach the ACL in any year, then we would close the fishery in Federal waters for the remainder of that year. At this time, the American Samoan Government does not have regulations in place to implement a complementary closure in territorial waters at the same time as a Federal closure. Therefore, NMFS expects there could continue to be fishing in territorial waters even after a closure of the bottomfish fishery in Federal waters, and this could offset the potential conservation benefits of restricting bottomfish harvest in Federal waters. As an additional AM, if the total annual catch (which includes catch from both Federal and territorial waters) exceeds the ACL during a year, we would close the fishery in Federal waters until NMFS and the Territory of American Samoa implement a coordinated management regime to ensure that the catch in both Federal and territorial waters is maintained at levels that allow the stock to rebuild. The rebuilding plan would remain in place until NMFS determines that the stock complex is rebuilt, which is expected to take 10 years if catches are maintained at the specified level. NMFS and the Council would review the rebuilding plan every two years and amend it, as necessary.
NMFS must receive comments on Amendment 5 by March 22, 2022 for consideration in the decision to approve, partially approve, or disapprove the amendment. Concurrent with our review of the amendment under the Magnuson-Stevens Act procedures, NMFS expects to publish in the
16 U.S.C. 1801
Forest Service, Agriculture (USDA).
Notice of opportunity to object to the revised Land Management Plan and the Regional Forester's list of species of conservation concern for the Nantahala and Pisgah National Forests.
The Forest Service, U.S. Department of Agriculture, is revising the Nantahala and Pisgah National Forests' Land Management Plan (Forest Plan). The Forest Service has prepared a Final Environmental Impact Statement (FEIS) for its revised Forest Plan, and a draft Record of Decision (ROD). This notice is to inform the public that the National Forests in North Carolina is initiating a 60-day period where individuals or entities with specific concerns about the Nantahala and Pisgah National Forests' revised Forest Plan and the associated FEIS may file objections for Forest Service review prior to the approval of the revised Forest Plan. This is also an opportunity to object to the Regional Forester's list of species of conservation concern for the Nantahala and Pisgah National Forests.
The publication date of the legal notice in the Nantahala and Pisgah National Forests' newspaper of record,
The Nantahala and Pisgah National Forests' revised Forest Plan, FEIS, draft ROD, species of conservation concern list, and other supporting information will be available for review at:
Objections must be submitted to the Objection Reviewing Officer by one of the following methods:
•
• Objections may be submitted electronically at
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Forest Planner, Michelle Aldridge at (828) 707-8391 or
Individuals who use telecommunication devices for the deaf/hard-of-hearing (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339, 24 hours a day, every day of the year, including holidays.
The decision to approve the revised Forest Plan and the Regional Forester's list of species of conservation concern for the Nantahala and Pisgah National Forests will be subject to the objection process identified in 36 CFR part 219 Subpart B (219.50 to 219.62).
Objections must be submitted to the Reviewing Officer at the address shown in the
(1) The objector's name and address along with a telephone number or email address if available. In cases where no identifiable name is attached to an objection, the Forest Service will attempt to verify the identity of the objector to confirm objection eligibility;
(2) Signature or other verification of authorship upon request (a scanned signature for electronic mail may be filed with the objection);
(3) Identification of the lead objector, when multiple names are listed on an objection. The Forest Service will communicate to all parties to an objection through the lead objector. Verification of the identity of the lead objector must also be provided if requested;
(4) The name of the plan, plan amendment, or plan revision being objected to, and the name and title of the responsible official;
(5) A statement of the issues and/or parts of the plan, plan amendment, or plan revision to which the objection applies;
(6) A concise statement explaining the objection and suggesting how the draft plan decision may be improved. If the objector believes that the plan, plan amendment, or plan revision is inconsistent with law, regulation, or policy, an explanation should be included;
(7) A statement that demonstrates the link between the objector's prior substantive formal comments and the content of the objection, unless the objection concerns an issue that arose after the opportunities for formal comment; and
(8) All documents referenced in the objection (a bibliography is not sufficient), except the following need not be provided:
a. All or any part of a Federal law or regulation,
b. Forest Service Directive System documents and land management plans or other published Forest Service documents,
c. Documents referenced by the Forest Service in the planning documentation related to the proposal subject to objection, and
d. Formal comments previously provided to the Forest Service by the objector during the proposed plan, plan amendment, or plan revision comment period.
It is the responsibility of the objector to ensure that the Reviewing Officer receives the objection in a timely manner. The regulations generally prohibit extending the length of the
The responsible official who will approve the ROD and the revised Forest Plan for the Nantahala and Pisgah National Forests is Forest Supervisor James Melonas, National Forests in North Carolina, 160 Zillicoa Street, Suite A, Asheville, NC 28801, and Phone: (828) 257-4200. The responsible official for the list of species of conservation concern is Regional Forester Ken Arney, USDA Forest Service Southern Region, 1720 Peachtree Road NW, Suite 760S, Atlanta, GA 30309.
The Regional Forester is the reviewing officer for the revised Forest Plan since the Forest Supervisor is the responsible official (36 CFR 219.56(e)). The decision to approve the species of conservation concern list will be subject to a separate objection process. The Chief of the Forest Service is the reviewing officer for species of conservation concern identification since the Regional Forester is the responsible official (36 CFR 219.56(e)(2)). This authority may be delegated to an individual Deputy Chief or Associate Deputy Chief for National Forest System, consistent with delegations of authority provided in the Forest Service Manual at sections 1235.4 and 1235.5.
Friday, January 21, 2022, 12:00 p.m. EST.
Meeting to take place by telephone and is open to the public by telephone: 800-259-2693, Conference ID #: 3653553.
Open to the public.
Commission business for the month of January.
Angelia Rorison: 202-376-7700;
Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that the Connecticut Advisory Committee to the U.S. Commission on Civil Rights will hold a fourth briefing via web conference or phone call on Monday, February 14, 2022, at 4:00 p.m. (ET). The purpose of the web conference is to hear from advocates and the general public on zoning in Connecticut.
February 14, 2022, Monday, at 4:00 p.m. (ET).
Barbara Delaviez at
This meeting is available to the public through the WebEx link and/or phone number/access code above. If joining only via phone, callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Individuals who are deaf, deafblind and hard of hearing. may also follow the proceedings by first calling the Federal Relay Service at 1-800-877-8339 and providing the Service with the call-in number found through registering at the web links provided for these meeting.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be emailed to Barbara de La Viez at
U.S. Commission on Civil Rights.
Announcement of meeting.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act that the Kansas Advisory Committee (Committee) will hold a meeting via web conference on, January 25, 2022, at 12:00 p.m. Central Time. The purpose of the meeting is for the committee to discuss potential panelists for the upcoming briefing(s) on voting.
The meetings will be held on:
• Tuesday, January 25, 2022, at 12:00 p.m. Central Time,
David Barreras, Designated Federal Officer, at
Members of the public may listen to this discussion through the above call-in number. An open comment period will be provided to allow members of the public to make a statement as time allows. Callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Individuals who are deaf, deafblind and
Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to David Barreras at
Records generated from this meeting may be inspected and reproduced at the Regional Programs Unit Office, as they become available, both before and after the meeting. Records of the meeting will be available via
Office of the Secretary, Department of Commerce.
Notice of availability of Department of Commerce's Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act report.
The Department of Commerce (DOC) is publishing a report on DOC federal financial assistance infrastructure programs subject to the Build America, Buy America Act Provisions of the Infrastructure Investment and Jobs Act (Pub. L. 117-58). The report is entitled “Department of Commerce's Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act.”
The DOC report will be available to the public on January 21, 2022.
The “Department of Commerce's Identification of Federal Financial Assistance Infrastructure Programs Subject to the Build America, Buy America Provisions of the Infrastructure Investment and Jobs Act” report is accessible at:
Questions regarding the report should be directed to John Geisen, Financial Assistance Policy and Oversight Division Director at 202-482-4248 or
On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (IIJA), which includes the “Build America, Buy America Act” (Act). The Act ensures that Federal infrastructure programs require the use of materials produced in the United States, increases the requirement for American-made content, and strengthens the waiver process associated with Buy American provisions. The Act requires that within 60 days of its enactment, January 14, 2022, each federal agency must submit to the Office of Management and Budget and Congress a report (60-day report) listing all Federal financial assistance programs for infrastructure administered by the agency. In these 60-day reports, agencies are required to identify and provide a list of which of these programs are “deficient,” as defined in the Act. These agency reports must also be published in the
The DOC report satisfies the requirements of section 70913 of the Act and is accessible at:
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; extension of public comment period.
NOAA is extending the public comment period associated with its request for information (RFI) on its policies and guidance documents for government-to-government consultation with federally recognized Indian Tribes. The RFI was published in the
The deadline for receipt of comments on the RFI published on November 24, 2021 (83 FR 26009), is extended by 30 days to February 24, 2022.
Responses should be submitted via email to
Heather Sagar,
On Wednesday, November 24, 2021, NOAA published an RFI seeking comments from Tribal Nations, Tribal officials, members of the public, and other interested parties to help identify appropriate updates or revisions to the following NOAA policies and guidance documents, which facilitate NOAA's implementation of E.O. 13175: (1) Tribal Consultation Handbook titled
NOAA has decided to extend the public comment period on the RFI by 30 days to Thursday, February 24, 2022, to allow opportunity for the public to continue to provide information on these important documents. All three documents can be viewed at this NOAA website:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permits.
Notice is hereby given that individuals and institutions have been issued Letters of Confirmation (LOCs) for activities conducted under the General Authorization for Scientific Research on marine mammals. See
The LOCs and related documents are available for review upon written request via email to
Amy Hapeman (LOC Nos. 24033, 25471, 25529, and 25638), Carrie Hubard (LOC Nos. 20346, 24045, 24067, 25527, and 25574), Erin Markin (LOC No. 23796), Shasta McClenahan, Ph.D. (LOC No. 23069), Courtney Smith, Ph.D. (LOC Nos. 19540 and 22587), and Sara Young (LOC Nos. 20386, 25751 and 25811) at the email listed above or 301-427-8401.
The requested LOCs have been issued under the authority of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice; request for written comments.
The National Oceanic and Atmospheric Administration (NOAA) is seeking written comments on its five-year review of the nomination for Hudson Canyon National Marine Sanctuary (NMS). Comments should focus solely on any new and relevant information relating to NOAA's 11 sanctuary nomination evaluation criteria. NOAA will pay particular attention to any additional details about the significance of the area's natural or cultural resources, changes to any threats to these resources, and evolving management efforts, or human uses in the proposed area (
Comments are due by February 7, 2022.
Comments may be submitted by one of the following methods:
•
•
LeAnn Hogan, Regional Operations Coordinator, NOAA Sanctuaries Eastern Region, 1305 East-West Highway, N/NMS, Silver Spring, MD 20910, or at
In June 2014, NOAA issued a final rule establishing the sanctuary nomination process (SNP), which details how communities may submit nominations to NOAA for consideration of national marine sanctuary designation (79 FR 33851). NOAA moves successful nominations to an inventory of areas that could be considered for national marine
In November 2019, NOAA issued a
NOAA is not proposing to designate Hudson Canyon as a national marine sanctuary with this action. Instead, comments should identify any new or changing information relative to NOAA's 11 sanctuary nomination evaluation criteria (
Should NOAA conclude that the Hudson Canyon NMS nomination no longer meets its evaluation criteria and decide to remove it from the inventory, NOAA would notify the nominator directly via letter, and the public via notice in the
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice; request for written comments.
The Office of National Marine Sanctuaries (ONMS) of the National Oceanic and Atmospheric Administration (NOAA) is requesting written comments to facilitate ONMS' five-year review of the nomination for the Mariana Trench National Marine Sanctuary (NMS) at the five-year interval. In particular, NOAA is requesting relevant information as it pertains to its 11 evaluation criteria for inclusion in the inventory. In this five-year review, NOAA will pay particular attention to any new information about the significance of the area's natural or cultural resources, changes to any threats to these resources, and any updates to the management framework of the area. NOAA has provided the original nominating parties, The Pew Charitable Trusts and Friends of the Marianas Trench, an opportunity to share their views on these same questions. Following this information gathering and internal analysis, NOAA will make a final determination on whether or not the Mariana Trench NMS nomination will remain in the inventory for another five-year period.
Written comments must be received by February 22, 2022. NOAA will conduct a virtual meeting on Saturday, February 12, 2022, from 10 a.m.-12 p.m. ChST (Guam/Commonwealth of the Northern Mariana Islands)/Friday, February 11, 2022, from 2 p.m.-4 p.m. HST (Hawai'i). NOAA may end the meeting before the time noted above if all those participating have completed their oral comments.
Comments may be submitted by one of the following methods:
•
•
•
•
Kristina Kekuewa, Pacific Islands Regional Director, NOAA Office of National Marine Sanctuaries, 1845 Wasp Blvd., Honolulu, Hawaii 96818, or at
In 2014, NOAA issued a final rule re-establishing the sanctuary nomination process (SNP), which details how communities may submit nominations of areas of the marine and Great Lakes environment for NOAA to consider for designation as national marine sanctuaries (79 FR 33851). NOAA moves successful nominations to an inventory of areas that could be considered for national marine sanctuary designation. The final rule re-establishing the SNP included a five-year limit on any nomination added to the inventory that NOAA does not advance for designation.
In November 2019, NOAA issued a
The nomination for Mariana Trench NMS was accepted to the national inventory on March 13, 2017, and is therefore scheduled to expire on March 13, 2022. The full nomination can be found at
NOAA is not proposing to designate the Mariana Trench NMS with this action. Instead, NOAA is seeking public comment on ONMS' five-year review of the nomination for Mariana Trench NMS. Accordingly, written comments submitted as part of this request should
Whether removing or maintaining the nomination for Mariana Trench NMS, NOAA would follow the same procedure for notifying the public NOAA followed when the nomination was submitted, including a letter to the nominator, a notice in the
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed deletions from the Procurement List.
The Committee is proposing to delete product(s) from the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Comments must be received on or before: February 20, 2022.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.
For further information or to submit comments contact: Michael R. Jurkowski, Telephone: (703) 785-6404, or email
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
The following product(s) are proposed for deletion from the Procurement List:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and deletions from the Procurement List.
This action adds product(s) and service(s) to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes product(s) from the Procurement List previously furnished by such agencies.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S Clark Street, Suite 715, Arlington, Virginia 22202-4149.
Michael R. Jurkowski, Telephone: (703) 785-6404, or email
On 10/22/2021, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List. This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3.
After consideration of the material presented to it concerning capability of qualified nonprofit agencies to provide the product(s) and service(s) and impact of the additions on the current or most recent contractors, the Committee has determined that the product(s) and service(s) listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organizations that will furnish the product(s) and service(s) to the Government.
2. The action will result in authorizing small entities to furnish the product(s) and service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) proposed for addition to the Procurement List.
Accordingly, the following product(s) and service(s) are added to the Procurement List:
On 9/24/2021, the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List. This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3.
After consideration of the relevant matter presented, the Committee has determined that the product(s) listed below are no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entities to furnish the product(s) and service(s) to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product(s) and service(s) deleted from the Procurement List.
Accordingly, the following product(s) and service(s) are deleted from the Procurement List:
U.S. Army Corps of Engineers, Department of Defense (DoD).
Notice.
The Assistant Secretary of the Army for Civil Works (ASACW) is soliciting applications to fill non-federal stakeholder representative member positions for the Committee on Levee Safety (Committee) in accordance with the National Levee Safety Program. The Committee on Levee Safety is being formed to advise the U.S. Army Corps of Engineers (Corps) and the Federal Emergency Management Agency (FEMA) on various aspects of developing the National Levee Safety Program. The Committee will be comprised of 14 voting members from state, local, regional, and tribal governments, as well as the private sector. This notice provides expectations for Committee members and announces the process for applying for membership on the Committee.
Applications must be submitted on or before March 22, 2022.
Interested persons may apply by submitting the required information to any of the following:
Ms. Tammy Conforti, 202-365-6586, email
(1) Provide feedback on broader stakeholder engagement approaches including identification of stakeholders and networks to be included.
(2) Publicize opportunities to participate in formal and informal stakeholder engagement activities.
(3) Strive to provide consensus advice on program and product scope, assumptions, criteria, and content for key deliverables.
(4) Provide feedback on approaches and materials to communicate program objectives and benefits to potential beneficiaries.
(5) Help identify and avoid implementation challenges that can be worked into the design of a program or implementation approach.
(1) The Assistant Secretary of the Army for Civil Works (ASACW) (or a designee of the ASACW) to represent the U.S. Army Corps of Engineers (USACE).
(2) The Administrator of the Federal Emergency Management Agency (FEMA) (or a designee of the Administrator) to represent FEMA.
(1) Eight representatives of state levee safety agencies, defined as current state government employees of a state agency that has regulatory authority over the safety of any non-federal levee in the state. For purposes of the Committee on Levee Safety, “state” is defined to include the fifty states, the District of Columbia, Commonwealth of Puerto Rico, and any other territory or possession of the United States. Regulatory authority refers to the ability to promulgate or enforce regulations for non-federal levees. There shall be one state representative from each of the geographical boundaries of the following eight civil works divisions of USACE:
The USACE eight civil works division boundaries can be found at:
(2) Two representatives of the private sector defined as those who are currently not directly employed by a public governmental entity, such as federal, state, local, or regional government or tribe. Private sector representatives can be working for public governmental entities through contractual or other types of agreements. Private sector representatives can be currently employed, retired, or affiliated with a nongovernmental organization.
(3) Two representatives of local or regional governmental agencies defined as current local or regional government employees of any subdivision within a state as defined by state law. For example, this could be a city, county, or other subdivision of a state.
(4) Two representatives of tribes defined as a member or direct employee of a federally recognized tribe or person identified by a federally recognized tribe to represent them.
(1) 5 members shall be appointed for a term of 1 year;
(2) 5 members shall be appointed for a term of 2 years; and
(3) 4 members, one state, private sector, local/regional, and tribal representative, shall be appointed for a term of 3 years.
(1) Each member of the Committee who is an officer or employee of the United States shall serve without compensation in addition to compensation received for the services of the member as an officer or employee of the United States; but shall be allowed a per diem allowance and reimbursable expenses for travel, as authorized for an employee of an agency under subchapter I of chapter 57 of title 5, while away from the home or regular place of business of the member in the performance of the duties of the Committee.
(2) Each member of the Committee who is not an officer or employee of the United States shall receive a stipend of $100 per business day to participate in full Committee meetings that are formally convened by USACE and FEMA and in coordination with the Committee Chairperson. Meeting durations must be a minimum of one full business day or more, not including travel time, to receive the stipend. In addition, non-federal members shall be allowed a per diem allowance and reimbursable expenses, as authorized for an employee of an agency under subchapter I of chapter 57 of title 5, while away from the home or official worksite of the member in the performance of services for the Committee for meetings convened by USACE and FEMA in coordination with the Chairperson.
(1) Strive to understand the widest possible range of diverse perspectives.
(2) Serve as a liaison with the various stakeholder groups represented to bring diverse viewpoints and interests into consideration.
(3) Enhance awareness of the National Levee Safety Program through each members' professional networks.
(4) Assist with developing balanced, acceptable solutions across stakeholder groups who may have competing or perceived to be competing interests.
(5) Be active participants in all Committee meetings, limiting distractions and other work to the maximum extent possible. Notify the Chairperson if attendance at a Committee meeting is not possible.
(6) Dedicate time to review materials provided in advance of each meeting.
(1) The Chairperson serves as the Committee representative for coordination with USACE and FEMA on topics or products in which the Committee will provide advice and development of meeting schedules and agendas.
(2) The Chairperson will foster an environment of collaboration in order to understand the widest possible range of diverse perspectives, while avoiding extensive focus on any one specific perspective.
(3) The Chairperson presides over the Committee to ensure the purpose and goals of the Committee are accomplished.
(4) The Chairperson presides over all Committee meetings to ensure meeting purposes are met.
(5) The Chairperson will lead the Committee to work towards consensus advice or recommendations that support a National approach to levee safety.
(6) The Chairperson has the ability to appoint a vice-Chairperson from the voting members to assume the duties of the Chairperson in cases of unexpected absences.
(1) The Committee may form temporary subcommittees or ad-hoc work groups comprised of volunteers from all levels of government and the private sector to provide advice on specific issues relevant to the National Levee Safety Program. The Committee shall seek concurrence from the non-voting member appointed by the ASACW to form a subcommittee or working group and its membership.
(2) Members of subcommittees or work groups must present their work to the Committee for full deliberation and discussion.
(3) Subcommittees or work groups have no authority to make decisions on behalf of the Committee.
(4) Members of subcommittees or work groups shall not be part of any transaction in which they have a direct or indirect personal financial interest or will obtain an economic benefit as a result of their service to the Committee, subcommittee, or working group.
(5) No compensation will be provided to members of subcommittees or work groups.
(1) Coordinate with the Chairperson to determine priority topics or issues in need of Committee feedback.
(2) Ensure that USACE and FEMA activities related to the National Levee Safety Program are synchronized with the advice and information from the Committee including overall scoping, review of deliverables, and incorporation of broader stakeholder feedback.
(3) Coordinate with the Federal advisory group regarding issues of federal alignment or common federal agency approaches.
(4) Inform the Committee on how Committee recommendations were considered.
(1) Work with the Chairperson to schedule and organize all meetings.
(2) Provide a qualified facilitator and administrative support for all Committee meetings.
(3) Ensure effective Committee operations.
(4) Serve as the point of contact between the Committee and the ASACW.
(1) All meetings will be convened by the USACE and FEMA in coordination with the Chairperson.
(2) It is anticipated that meetings will be held in-person whenever possible but may be conducted virtually if necessary.
(3) It is estimated that the Committee on Levee Safety will meet for a duration of 3 business days, allowing for travel on Mondays and Fridays, on a frequency of approximately every 4 months.
(4) Scheduling of meetings will be done in advance and in coordination with Committee members to maximize participation.
(5) Meetings will be held in a variety of locations in the U.S. to promote field exploration, stakeholder feedback and equity of travel time for participants.
(6) Meeting notes will be available for review within one week of the end of the meeting.
(1) To the extent possible, the Committee will provide consensus advice and recommendations in writing to the USACE and FEMA non-voting members. Should a case arise where consensus cannot be achieved, the Chairperson may call for a vote among the voting members in order to reach a final recommendation. Areas of consensus, divergence, or those who abstain will be documented and provided to USACE and FEMA.
(2) At the request of the Chairperson, USACE may provide technical writing support to assist the Committee with documentation of recommendations.
(3) After each time the Committee provides recommendations, USACE and FEMA will inform the Committee within a reasonable amount of time whether the recommendations were incorporated or reasons the recommendations were not incorporated.
(1) State Government Representative. Defined as a current state government employee of a state agency that has regulatory authority over the safety of any non-federal levee in the state. Regulatory authority refers to the ability to promulgate or enforce regulations for non-federal levees. The following are the desired types of expertise and experience for state government representatives on the Committee.
• Developing state law, state regulations, local ordinances, or state-level public policy.
• Overseeing enforcement or compliance of state law, state regulations, or local ordinances, including permitting (ideally related to floodplain management or environmental compliance).
• Flood risk management projects or programs at the state, watershed level or with multiple states.
• Applying for or distributing grants or other federal assistance.
• Planning, organizing, coordinating or implementing community level programs or working with disadvantaged communities.
• Implementing the National Flood Insurance Program, including state hazard mitigation planning, or the National Dam Safety Program at the state level.
• Resource or asset management at the state level.
• Emergency planning, response, or coordination at the state level.
• Green infrastructure, environmental mitigation/restoration, or natural benefits of floodplains.
(2) Private Sector Representative. Defined as a person who is not directly employed by a public governmental entity, such as federal, state, local, or regional government or tribe. Private sector representatives can be working for public governmental entities through contractual or other types of agreements. Private sector representatives can be currently employed, retired, or affiliated with a nongovernmental organization. The following are the desired types of expertise and experience for the private sector representatives on the Committee.
• Evaluating or assessing existing levees or dams or floodplain related scenarios, including levee accreditation evaluations for the National Flood Insurance Program.
• Performing risk assessments on dams or levees.
• Design and construction or operation/maintenance/inspections of levees or dams.
• Planning, organizing, coordinating or implementing community/stakeholder outreach; or expertise in social sciences.
• Green infrastructure, environmental mitigation/restoration, or natural benefits of floodplains.
• Relevant legal expertise, knowledge, and experience (
• Floodplain management, flood hazard mitigation, or flood preparedness/warning/recovery.
• Knowledge and expertise in climate science.
• Community planning or working with disadvantaged communities.
• Developing public policy or public programs.
(3) Local or Regional Government Representative. Defined as a current
• Developing local/regional regulations, ordinances, or public policy.
• Overseeing enforcement or compliance of regulations or ordinances, including permitting (ideally related to floodplain management or environmental compliance).
• Flood risk management projects or programs at the local or watershed level.
• Planning, organizing, coordinating or implementing community level programs or community outreach efforts, including with disadvantaged communities.
• Implementing the National Flood Insurance Program, including development or implementing floodplain management plans or risk communication efforts.
• Emergency planning, response, or coordination at the community level.
• Green infrastructure, environmental mitigation/restoration, or natural benefits of floodplains.
(4) Tribal Representative. Defined as a member or direct employee of a federally recognized tribe or person identified by a federally recognized tribe to represent them. Tribal representatives should have knowledge and awareness of tribal interests or concerns related to lands or resources that may be impacted by levees.
(1)
(2)
•
•
•
•
(3) Statement of Qualification (not to exceed 750 words). Please provide a written statement that describes your areas of expertise related to the stakeholder category you would be representing (state, private sector, local/regional, or tribal).
(4) Statement of Participation (not to exceed 500 words). Please provide a written statement as to why you should be appointed as a stakeholder representative and how your participation will contribute to fulfilling the roles and responsibilities of the Committee on Levee Safety.
(5) Experience with Collaboration (not to exceed 500 words). Please provide a written statement describing past experience(s) you have had working collaboratively with a group of individuals representing varied interests towards achieving a mutual goal. Please include the outcome or results of such effort(s).
(6) Acknowledgements. Please include a statement that you have read and agree to the following:
• Your willingness to participate in a virtual interview as part of the selection process if requested or provide additional information if needed.
• Your ability and willingness to accept up to a three-year commitment to serve on the Committee on Levee Safety without compensation, other than the nominal stipend and travel expenses.
• Your willingness to adhere to and support the Committee on Levee Safety charter.
• Your commitment to seek balanced recommendations that address multiple interests and concerns.
• Your willingness to commit the time that may be required to participate on the Committee.
• Your consent that this application may become part of the public record.
• Your acknowledgment that if appointed, as a member you cannot be part of any transaction in which you have a direct or indirect personal financial interest or will obtain an economic benefit as a result of your participation on the Committee nor can you enter into a relationship with vendors for pay in matters that are currently being considered by the Committee.
• Consent that if appointed, your name may be listed on a public website or other Committee on Levee Safety documents.
• Verification that all information submitted is correct and true to the best of your knowledge.
Bonneville Power Administration (BPA), Department of Energy (DOE).
Notice of document availability.
Copies of the Bonneville Purchasing Instructions (BPI), which contain the policy and establish the procedures that BPA uses in the solicitation, award, and administration of its purchases of goods and services, including construction, are available in printed form or at the following internet address:
Unbound copies of the BPI or BFAI may be obtained by sending a request to the Head of the Contracting Activity, Routing CP-7, Bonneville Power Administration, P.O. Box 3621, Portland, Oregon 97208-3621.
Nicholas M. Jenkins, Head of the Contracting Activity; direct telephone (503) 230-5498; or email
BPA was established in 1937 as a Federal Power Marketing Agency in the Pacific Northwest. BPA operations are financed from rate payer revenues rather than annual appropriations. BPA's purchasing operations are conducted under 16 U.S.C. 832
Bonneville Power Administration, Department of Energy.
Notice of information collection; request for comments.
The Department of Energy (DOE), Bonneville Power Administration (BPA), invites public comment on a collection of information that BPA is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.
Comments regarding this proposed information collection must be received on or before March 14, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Requests for additional information or copies of the information collection instrument and instructions should be directed to Attn: Theodore Rydmark, Privacy Program, by email at
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
This information collection request contains:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
Bonneville Power Administration, Department of Energy.
Notice of information collection; request for comments.
The Bonneville Power Administration (BPA), Department of Energy (DOE), invites public comment on a collection of information that BPA is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.
Comments regarding this proposed information collection must be received on March 14, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Requests for additional information or copies of the information collection instrument and instructions should be directed to Attn: Theodore Rydmark, Privacy Program, or by email at
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
This information collection request contains:
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
Take notice that on January 7, 2022, Columbia Gas Transmission, LLC (Columbia), 700 Louisiana Street, Suite 1300, Houston, TX 77002-2700 filed in the above referenced docket a prior notice pursuant to sections 157.205 and 157.216 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act (NGA), requesting authorization to abandon one injection/withdrawal well and associated pipelines and appurtenances, located in its Weaver Storage Field in, Richland County, Ohio. Columbia proposes to abandon these facilities under authorities granted by its blanket certificate issued in Docket No. CP83-76-000.
In addition to publishing the full text of this document in the
Any questions concerning this application should be directed to David A. Alonzo, Manager, Project Authorizations, Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 1300, Houston, Texas, 77002-2700, at (832) 320-5477 or
Pursuant to Section 157.9 of the Commission's Rules of Practice and Procedure,
There are three ways to become involved in the Commission's review of this project: You can file a protest to the project, you can file a motion to intervene in the proceeding, and you can file comments on the project. There is no fee or cost for filing protests, motions to intervene, or comments. The deadline for filing protests, motions to intervene, and comments is 5:00 p.m. Eastern Time on March 15, 2022. How to file protests, motions to intervene, and comments is explained below.
Pursuant to section 157.205 of the Commission's regulations under the NGA,
Protests must comply with the requirements specified in section 157.205(e) of the Commission's regulations,
Any person has the option to file a motion to intervene in this proceeding. Only intervenors have the right to request rehearing of Commission orders issued in this proceeding and to subsequently challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
To intervene, you must submit a motion to intervene to the Commission in accordance with Rule 214 of the Commission's Rules of Practice and Procedure
All timely, unopposed motions to intervene are automatically granted by operation of Rule 214(c)(1). Motions to intervene that are filed after the intervention deadline are untimely and may be denied. Any late-filed motion to intervene must show good cause for being late and must explain why the time limitation should be waived and provide justification by reference to factors set forth in Rule 214(d) of the Commission's Rules and Regulations. A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies (paper or electronic) of all documents filed by the applicant and by all other parties.
Any person wishing to comment on the project may do so. The Commission considers all comments received about the project in determining the appropriate action to be taken. To ensure that your comments are timely and properly recorded, please submit your comments on or before March 15, 2022. The filing of a comment alone will not serve to make the filer a party to the proceeding. To become a party, you must intervene in the proceeding.
There are two ways to submit protests, motions to intervene, and comments. In both instances, please reference the Project docket number CP22-38-000 in your submission.
(1) You may file your protest, motion to intervene, and comments by using the Commission's eFiling feature, which is located on the Commission's website (
(2) You can file a paper copy of your submission by mailing it to the address below. Your submission must reference the Project docket number CP22-38-000.
The Commission encourages electronic filing of submissions (option 1 above) and has eFiling staff available to assist you at (202) 502-8258 or
Protests and motions to intervene must be served on the applicant either by mail or email (with a link to the document) at: 700 Louisiana Street, Suite 1300, Houston, TX 77002-2700 or
Throughout the proceeding, additional information about the project will be available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. For more information and to register, go to
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b. Project No.: 2336-101.
c.
d.
e.
f.
g.
h.
i.
j. This application is not ready for environmental analysis at this time.
k. The Lloyd Shoals Project consists of: (1) The 4,750-acre Lake Jackson at normal pool elevation of 530 feet Plant Datum (PD) with a gross storage capacity of 107,000 acre-feet; (2) a 1,600-foot-long, 106-foot-high concrete gravity dam consisting of a 143-foot-long non-overflow section, a 198-foot-long powerhouse intake section with six, 12-foot-high by 12-foot-wide octagonal water passages supplying the generating units, a 728.5-foot-long spillway section consisting of a trash gate and an Obermeyer gate system, and a 530-foot-long earth embankment tie-in; (3) a concrete and brick powerhouse containing six horizontal Francis turbine-generator units, each rated at 3.0-megawatts (MW), for a total authorized installed capacity of 18-MW; (4) a 2,100-foot-long saddle dike approximately 3,000 feet upstream of the east end of the main dam; (5) a 500-foot-long auxiliary spillway, topped with 10-foot-high flashboards, located 900 feet southwest of the main dam, which includes a 560-foot-long, 6-foot-high sacrificial earth embankment; (6) two 2.3-kilovolt generator leads connecting the powerhouse to a substation located at the west dam abutment; and (7) appurtenant facilities. Georgia Power proposes no modifications to existing project facilities.
The Lloyd Shoals Project operates in a modified run-of-river mode to generate power during peak demand. Reservoir elevations are maintained between 530 feet PD and 527 feet PD year-round, excluding planned drawdowns and drought. The project provides a continuous minimum flow of 400 cubic feet per second (cfs), or inflow, to the Ocmulgee River downstream for the protection and enhancement of fish and wildlife resources and other downstream resources. Georgia Power proposes no changes to project operation.
Georgia Power proposes environmental measures to improve and enhance water quality, aquatic habitat, and recreation facilities. Georgia Power also proposes plans for protection of shoreline resources and historic properties.
l. A copy of the application can be viewed on the Commission's website at
m. You may also register online at
n.
o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
The filings are accessible in the Commission's eLibrary system (
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Environmental Protection Agency (EPA).
Notice.
There will be a 3-day public peer review virtual meeting of the Science Advisory Committee on Chemicals (SACC) to consider and review the draft EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0. In addition, EPA is announcing the availability of and soliciting public comments on the draft approach, which will be presented as a screening level methodology for assessing potential air and water chemical exposures to fenceline communities.
Due to public health concerns related to COVID-19, the EPA Docket Center and Reading Room are open to the public by appointment only. For further information on the EPA Docket Center (EPA/DC) services, docket contact information and the current status of the EPA/DC and Reading Room, please visit
Dr. Alaa Kamel, DFO, Office of Chemical Safety and Pollution Prevention (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8450; email address:
This action is directed to the public in general. This action may be of interest to persons who are or may be required to conduct testing and those interested in risk evaluations of chemical substances under TSCA. Since other entities may also be interested in this action, the EPA has not attempted to describe all the specific entities that may be affected by this action.
Information about the SACC and this meeting is available on the SACC website at
1.
2.
The SACC was established by EPA in 2016 and operates in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. Appendix 2
The SACC is comprised of experts in: Toxicology; Human health and environmental risk assessment; Exposure assessment; and related sciences (
The purpose of this virtual public meeting of the SACC is to consider and review the draft document entitled “EPA TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0,” which will be presented as a screening level methodology for assessing potential air and water chemical exposures to fenceline communities.
EPA published ten final risk evaluations between 2020 and 2021 under the Toxic Substances Control Act (TSCA) as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act in June 2016. During the course of finalizing many of these first 10 risk evaluations, a policy decision was made by the previous Administration that EPA not assess air and water exposure pathways that fall under the jurisdiction of other EPA-administered laws. This policy decision was reversed in June 2021. EPA is presenting Version 1.0 of a screening level methodology for assessing potential air and water pathway chemical exposures to fenceline communities. Along with presenting this methodology, EPA will also present results of applying the screening methodology (case studies) to 1-Brompropane or 1-BP (air pathway), n-methylpyrrolidone or NMP (water
EPA's background documents, related supporting materials, and draft charge questions to the SACC are available in the docket established for this meeting at
After the public meeting, the SACC will prepare meeting minutes summarizing its recommendations to the EPA. The meeting minutes will be posted on the SACC website and in the docket.
To participate in the Exposures to Fenceline Communities virtual public meeting, please follow the instructions in this unit.
To ensure proper receipt of comments it is imperative that you identify docket ID No. EPA-HQ-OPPT-2021-0415 in the subject line on the first page of your comments.
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2.
Oral comments before the SACC during the peer review virtual meeting are limited to 5 minutes unless arrangements have been made prior to the date set in the
This meeting is virtual and viewed via webcast. For information on how to first register and then view the webcast, please refer to the SACC website at
Environmental Protection Agency (EPA).
Notice of availability.
This notice announces the broadly applicable alternative test method approval decisions that the Environmental Protection Agency (EPA) made under and in support of New Source Performance Standards (NSPS) and the National Emission Standards for Hazardous Air Pollutants (NESHAP) between January 1, 2021, and December 31, 2021.
An electronic copy of each alternative test method approval document is available at
This notice will be of interest to entities regulated under title 40 Code of Federal Regulations (CFR) parts 59, 60, 61, 63 and 65; state, local, and tribal agencies; and the EPA Regional offices responsible for implementation and enforcement of regulations under 40 CFR parts 59, 60, 61, 63, and 65.
You may access copies of the broadly applicable alternative test method approval documents at
This notice identifies broadly applicable alternative test methods that the EPA approved in 2020 under the New Source Performance Standards (NSPS), 40 CFR part 60, and the National Emission Standards for Hazardous Air Pollutants (NESHAP) programs, 40 CFR parts 61 and 63. See Table 1 of this notice for the summary of these test methods. Source owners and operators may voluntarily use these broadly applicable alternative test methods in lieu of otherwise required test methods or related testing procedures. Use of these broadly applicable alternative test methods are not intended to and should not change the applicable emission standards.
The Administrator has the authority to approve the use of alternative test methods for compliance with requirements under 40 CFR parts 60, 61, and 63. This authority is found in 40 CFR 60.8(b)(3), 61.13(h)(1)(ii), and 63.7(e)(2)(ii). Additional and similar authority can be found in 40 CFR 59.104(f) and 65.158(a)(2). The criteria for approval and procedures for submission and review of broadly applicable alternative test methods are explained in a previous
As also explained in the January 30, 2007 notice, our approval decisions
Use of approved alternative test methods are not mandatory but rather permissive. Sources are not required to employ such a method but may choose to do so in appropriate circumstances. As specified in 40 CFR 63.7(f)(5), however, a source owner or operator electing to use an alternative method for 40 CFR part 63 standards must continue to use the alternative method until otherwise authorized. Source owners or operators should, therefore, review the specific broadly applicable alternative method approval decision at
This notice specifies six broadly applicable alternative test methods that the EPA approved between January 1, 2021, and December 31, 2021. The alternative method decision letter/memo designation numbers, test methods affected, sources allowed to use this alternative, and method modifications or alternative methods allowed are summarized in Table 1 of this notice. A summary of approval documents was previously made available on our Technology Transfer Network between January 1, 2021, and December 31, 2021. For more detailed information, please refer to the complete copies of these approval documents available at
As also explained in our January 30, 2007 notice, we will revisit approvals of alternative test methods in response to written requests or objections indicating that a particular approved alternative test method either should not be broadly applicable or that its use is not appropriate or should be limited in some way. Any objection to a broadly applicable alternative test method, as well as the resolution of that objection, will be announced at
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Written PRA comments should be submitted on or before March 22, 2022. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email
For additional information about the information collection, contact Nicole Ongele, (202) 418-2991.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments and recommendations for the proposed information collection should be submitted on or before January 21, 2022.
Comments should be sent to
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
The Commission delegated authority to WCB/OEA to implement the Third Mandatory Data Collection—including determining and describing the types of information to require providers to submit regarding their operations, costs, demand, and revenues—and directed WCB/OEA to develop a template and instructions for the collection.
Pursuant to their delegated authority, WCB/OEA drafted proposed instructions, a template, and a certification form for the Third Mandatory Data Collection.
On September 22, 2021, WCB/OEA released the Third Mandatory Data Collection (MDC) Public Notice (DA 21-1192, WC Docket No. 12-375 (WCB/OEA Sept. 22. 2021)), seeking comment on all aspects of the proposed collection, including the draft instructions, template, and certification form. The MDC Public Notice was published in the
After considering the comments and reply comments filed in response to the MDC Public Notice and the 60-Day Notice, WCB/OEA released an Order on January 18, 2022 adopting the Third Mandatory Data Collection, and issuing the related instructions, template, and certification form.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments, relevant information, or documents regarding the agreement to the Secretary by email at
Centers for Medicare & Medicaid Services, Health and Human Services (HHS).
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by March 22, 2022.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' website address at website address at
William N. Parham at (410) 786-4669.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
The Medicare Current Beneficiary Survey (MCBS) is the most comprehensive and complete survey available on the Medicare population and is essential in capturing data not otherwise collected through our operations. The MCBS is a nationally-representative, longitudinal survey of Medicare beneficiaries that we sponsor and is directed by the Office of Enterprise Data and Analytics (OEDA). MCBS data collection includes both in-person and phone interviewing. The survey captures beneficiary information whether aged or disabled, living in the community or facility, or serviced by managed care or fee-for-service. Data produced as part of the MCBS are enhanced with our administrative data (
The MCBS continues to provide unique insight into the Medicare program and helps CMS and our external stakeholders better understand and evaluate the impact of existing programs and significant new policy initiatives. In the past, MCBS data have been used to assess potential changes to the Medicare program. For example, the MCBS was instrumental in supporting the development and implementation of the Medicare prescription drug benefit by providing a means to evaluate prescription drug costs and out-of-pocket burden for these drugs to Medicare beneficiaries. Beginning in 2023, this proposed revision to the clearance will add a few new measures to existing questionnaire sections and will remove COVID-19-related content that is no longer relevant for administration. New respondent materials are also included in this request. The revisions will result in a net decrease in respondent burden as compared to the current clearance due to the removal of COVID-19 items.
2.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry and FDA staff entitled “Collecting and Providing 702(b) Portions of FDA Official Samples—Questions and Answers.” This draft guidance is intended to assist industry and FDA staff with issues and questions related to the requirements for FDA to collect and provide a part of an official sample of an article to any person named on the label of the article, or the owner thereof, or his attorney or agent.
Submit either electronic or written comments on the draft guidance by February 22, 2022 to ensure that we consider your comment on this draft guidance before we begin work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Chris Henderson, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20857 240-402-8186,
FDA is announcing the availability of a draft guidance for industry and FDA staff entitled “Collecting and Providing 702(b) Portions of FDA Official Samples—Questions and Answers.” Section 702 of the FD&C Act (21 U.S.C. 372) authorizes FDA to conduct examinations and investigations and to collect samples. Under section 702(b) of the FD&C Act, when FDA collects a sample of a food, drug, or cosmetic for analysis, FDA must, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent. Additionally, FDA was authorized to establish, by regulation, reasonable exceptions to, and impose reasonable terms and conditions relating to, the requirement to collect and provide a 702(b) portion of an official sample to the owner, as necessary for the proper administration of the provisions of the FD&C Act. FDA's regulation at 21 CFR 2.10 was issued to establish those reasonable exceptions, and terms and conditions, and to implement section 702(b) of the FD&C Act.
This draft guidance is intended to assist industry and FDA staff with issues and questions related to the requirements for FDA to collect and provide portions of official samples under section 702(b) of the FD&C Act and its implementing regulation in 21 CFR 2.10.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Collecting and Providing 702(b) Portions of FDA Official Samples—Questions and Answers.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Persons with access to the internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the
The announcement of the guidances is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of these guidances to the address noted in table 1. Send two self-addressed adhesive labels to assist that office in processing your requests. See the
Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911, or Erica Takai, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.
On January 31, 2020, as a result of confirmed cases of COVID-19, and after consultation with public health officials as necessary, the Secretary of Health and Human Services (HHS), pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d), determined that a PHE exists and has existed since January 27, 2020, nationwide.
In the
The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID-19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID-19-related guidances that are posted on FDA's website.
Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID-19-related guidances:
Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)).
These guidances are being issued consistent with FDA's good guidance practices regulation (§ 10.115). The guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
While this guidance contains no collection of information, it does refer to previously approved FDA collections of information (listed in table 2). Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:
The guidances listed below refer to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the table below (table 3). These guidances also contain a new collection of information not approved under a current collection. These new collections of information have been granted a public health emergency (PHE) waiver from the PRA by the Department of Health and Human Services (HHS) on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at
Persons with access to the internet may obtain COVID-19-related guidances at:
• FDA web page entitled “COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,” available at
• FDA web page entitled “Search for FDA Guidance Documents” available at
•
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the
The Authorization for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test is revoked as of December 10, 2021. The Authorizations for the SARS-COV-2 R-GENE, Atellica IM SARS-CoV-2 IgG (COV2G), and ADVIA Centaur SARS-CoV-2 IgG (COV2G) are revoked as of December 17, 2021. The Authorization for the Xpert Omni SARS-CoV-2 is revoked as of December 20, 2021.
Submit written requests for a single copy of the revocations to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the revocations may be sent. See the
Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-0002, 240-402-8155 (this is not a toll-free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. On April 1, 2020, FDA issued an EUA to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the
On December 7, 2021, Cellex requested withdrawal of, and on December 10, 2021, FDA revoked, the Authorization for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test. Because Cellex requested that FDA withdraw the Authorization and FDA understands the product is no longer being distributed, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 10, 2021, FDA received a request from BioMérieux SA for the revocation of, and on December 17, 2021, FDA revoked, the Authorization for the SARS-COV-2 R-GENE. Because BioMérieux SA notified FDA that BioMérieux SA has decided to no longer commercially support the authorized product and requested FDA revoke the Authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 9, 2021, FDA received a request from Siemens Healthcare Diagnostics Inc. for the voluntary removal of, and on December 17, 2021, FDA revoked, the Authorization for the Atellica IM SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no longer market the authorized product and requested FDA voluntarily remove the Atellica IM SARS-CoV-2 IgG (COV2G) from FDA's list of authorized devices, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 9, 2021, FDA received a request from Siemens Healthcare Diagnostics Inc. for the voluntary removal of, and on December 17, 2021, FDA revoked, the Authorization for the ADVIA Centaur SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no longer market the authorized product and requested FDA voluntarily remove the ADVIA Centaur SARS-CoV-2 IgG (COV2G) from FDA's list of authorized devices, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 17, 2021, FDA received a request from Cepheid for the revocation of, and on December 20, 2021, FDA revoked, the Authorization for the Xpert Omni SARS-CoV-2. Because Cepheid has notified FDA that Cepheid has not commercially distributed any of the Xpert Omni SARS-CoV-2 product due to the current public clinical needs being met by Cepheid's other EUA tests that are available and requested FDA revoke the EUA for the Xpert Omni SARS-CoV-2, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization.
An electronic version of this document and the full text of the revocations are available on the internet at
Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUAs for
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this ICR should be received no later than March 22, 2022.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information collection request title for reference.
Non-substantive revisions also include updates to terminology, goals, benchmark data sources, and significance sections included in the measures' detail sheets. A performance measure detail sheet defines and describes each performance measure. Forms and detail sheets showing the proposed revisions are available upon request.
This revision will facilitate more efficient and accurate reporting of information related to capacity building activities, financial and demographic data, and training activities.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will (1) hear presentations from six subcommittees on findings and potential actions from reports prepared for the TBDWG to consider and (2) further discuss plans for developing the next report to the HHS Secretary and Congress on federal tick-borne activities and research, taking into consideration the 2018 and 2020 report. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.
The meeting will be held online via webcast on February 28-March 1, 2022 from approximately 9:00 a.m. to 5:00 p.m. ET (times are tentative and subject to change) each day. The confirmed times and agenda items for the meeting will be posted on the TBDWG web page at
James Berger, Designated Federal Officer for the TBDWG; Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L600, Washington, DC 20024. Email:
Registration information can be found on the meeting website at
Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS).
Notice.
The National Advisory Committee on Children and Disasters (NACCD or the Committee) is required by section 2811A of the PHS Act as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) and governed by the provisions of the Federal Advisory Committee Act (FACA). The NACCD shall evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS to support and enhance all-hazards public health and medical preparedness, response, and recovery aimed at meeting the unique needs of children and their families across the entire spectrum of their wellbeing. The Secretary of HHS has formally delegated authority to operate the NACCD to ASPR.
The NACCD will conduct an inaugural public meeting (virtual) on February 17, 2022. The new advisory committee will be sworn in along with the presentation and discussion of challenges, opportunities, and priorities for national public health and medical preparedness, response and recovery, specific to the needs of children and their families in disasters. A more
Members of the public may attend the meeting via a toll-free phone number or Zoom teleconference, which requires pre-registration. The meeting link to pre-register will be posted on
Zhoowan Jackson, NACCD Designated Federal Officer, Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), Washington, DC; 202-205-4217,
The NACCD invites those who are involved in or represent a relevant industry, academia, health profession, health care consumer organization, or state, Tribal, territorial or local government to request up to four minutes to address the committee in person via Zoom. Requests to provide remarks to the NACCD during the public meeting must be sent to
Department of Health and Human Services.
Notice.
This notice provides an update of the Department of Health and Human Services (HHS) poverty guidelines to account for last calendar year's increase in prices as measured by the Consumer Price Index.
January 12, 2022 unless an office administering a program using the guidelines specifies a different effective date for that particular program.
Office of the Assistant Secretary for Planning and Evaluation, Room 404E, Humphrey Building, Department of Health and Human Services, Washington, DC 20201.
For information about how the guidelines are used or how income is defined in a particular program, contact the Federal, state, or local office that is responsible for that program. For information about poverty figures for immigration forms, the Hill-Burton Uncompensated Services Program, and the number of people in poverty, use the specific telephone numbers and addresses given below.
For general questions about the poverty guidelines themselves, contact Kendall Swenson, Office of the Assistant Secretary for Planning and Evaluation, Room 404E.3, Humphrey Building, Department of Health and Human Services, Washington, DC 20201—telephone: (202) 795-7309—or visit
For information about the percentage multiple of the poverty guidelines to be used on immigration forms such as USCIS Form I-864, Affidavit of Support, contact U.S. Citizenship and Immigration Services at 1-800-375-5283. You also may visit
For information about the Hill-Burton Uncompensated Services Program (free or reduced-fee health care services at certain hospitals and other facilities for persons meeting eligibility criteria involving the poverty guidelines), contact the Health Resources and Services Administration Information Center at 1-800-638-0742. You also may visit
For information about the number of people in poverty, visit the Poverty section of the Census Bureau's website at
Section 673(2) of the Omnibus Budget Reconciliation Act (OBRA) of 1981 (42 U.S.C. 9902(2)) requires the Secretary of the Department of Health and Human Services to update the poverty guidelines at least annually, adjusting them on the basis of the Consumer Price Index for All Urban Consumers (CPI-U). The poverty guidelines are used as an eligibility criterion by Medicaid and a number of other Federal programs. The
As required by law, this update is accomplished by increasing the latest published Census Bureau poverty thresholds by the relevant percentage change in the Consumer Price Index for All Urban Consumers (CPI-U). The guidelines in this 2022 notice reflect the 4.7 percent price increase between calendar years 2020 and 2021. After this inflation adjustment, the guidelines are rounded and adjusted to standardize the differences between family sizes. In rare circumstances, the rounding and standardizing adjustments in the formula result in small decreases in the poverty guidelines for some household sizes even when the inflation factor is not negative. In cases where the year-to-year change in inflation is not negative and the rounding and standardizing adjustments in the formula result in reductions to the guidelines from the previous year for some household sizes, the guidelines for the affected household sizes are fixed at the prior year's guidelines. As in prior years, these 2022 guidelines are roughly equal to the poverty thresholds for calendar year 2021, which the Census Bureau expects to publish in final form in September 2022.
The poverty guidelines continue to be derived from the Census Bureau's current official poverty thresholds; they are not derived from the Census Bureau's Supplemental Poverty Measure (SPM).
The following guideline figures represent annual income.
For families/households with more than 8 persons, add $4,720 for each additional person.
For families/households with more than 8 persons, add $5,900 for each additional person.
For families/households with more than 8 persons, add $5,430 for each additional person.
Separate poverty guideline figures for Alaska and Hawaii reflect Office of Economic Opportunity administrative practice beginning in the 1966-1970 period. (Note that the Census Bureau poverty thresholds—the version of the poverty measure used for statistical purposes—have never had separate figures for Alaska and Hawaii.) The poverty guidelines are not defined for Puerto Rico or other outlying jurisdictions. In cases in which a Federal program using the poverty guidelines serves any of those jurisdictions, the Federal office that administers the program is generally responsible for deciding whether to use the contiguous-states-and-DC guidelines for those jurisdictions or to follow some other procedure.
Due to confusing legislative language dating back to 1972, the poverty guidelines sometimes have been mistakenly referred to as the “OMB” (Office of Management and Budget) poverty guidelines or poverty line. In fact, OMB has never issued the guidelines; the guidelines are issued each year by the Department of Health and Human Services. The poverty guidelines may be formally referenced as “the poverty guidelines updated periodically in the
Some federal programs use a percentage multiple of the guidelines (for example, 125 percent or 185 percent of the guidelines), as noted in relevant authorizing legislation or program regulations. Non-Federal organizations that use the poverty guidelines under their own authority in non-Federally-funded activities also may choose to use a percentage multiple of the guidelines.
The poverty guidelines do not make a distinction between farm and non-farm families, or between aged and non-aged units. (Only the Census Bureau poverty thresholds have separate figures for aged and non-aged one-person and two-person units.)
This notice does not provide definitions of such terms as “income” or “family” as there is considerable variation of these terms among programs that use the poverty guidelines. The legislation or regulations governing each program define these terms and determine how the program applies the poverty guidelines. In cases where legislation or regulations do not establish these definitions, the entity that administers or funds the program is responsible to define such terms as “income” and “family.” Therefore, questions such as net or gross income, counted or excluded income, or household size should be directed to the entity that administers or funds the program.
Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.
Notice.
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a virtual meeting. The meeting will be open to the public and public comment will be heard during the meeting.
The meeting will be held February 10-11, 2022. The confirmed meeting times and agenda will be posted on the NVAC website at
Instructions regarding attending this meeting will be posted online at:
Ann Aikin, Acting Designated Federal Officer, at the Office of Infectious Disease and HIV/AIDS Policy, U.S. Department of Health and Human Services, Mary E. Switzer Building, Room L618, 330 C Street SW, Washington, DC 20024. Email:
Pursuant to Section 2101 of the Public Health Service Act (42 U.S.C. 300aa-1), the Secretary of HHS was mandated to establish the National Vaccine Program to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines. The NVAC was established to provide advice and make recommendations to the Director of the National Vaccine Program on matters related to the Program's responsibilities. The Assistant Secretary for Health serves as Director of the National Vaccine Program.
The NVAC celebrates 35 years and will kick off the meeting reflecting on accomplishments and outling
Members of the public will have the opportunity to provide comment at the NVAC meeting during the public comment period designated on the agenda. Public comments made during the meeting will be limited to three minutes per person to ensure time is allotted for all those wishing to speak. Individuals are also welcome to submit written comments in advance. Written comments should not exceed three pages in length. Individuals submitting comments should email their written comments or their request to provide a comment during the meeting to
U.S. Immigration and Customs Enforcement (ICE); Department of Homeland Security (DHS).
This notice announces that the Secretary of Homeland Security (Secretary) is amending the DHS STEM Designated Degree Program List by adding 22 qualifying fields of study and a corresponding Department of Education Classification of Instructional Programs (CIP) code for each. The list is used to determine whether a degree obtained by certain F-1 nonimmigrant students following the completion of a program of study qualifies as a science, technology, engineering, or mathematics (STEM) degree as determined by DHS, for the F-1 student to be eligible to apply for a 24-month extension of their post-completion optional practical training (OPT).
DHS adopts the list announced in this notice as of January 21, 2022.
Sharon Snyder, Unit Chief, Policy and Response Center Unit, Student and Exchange Visitor Program; U.S. Immigration and Customs Enforcement, 500 12th Street SW, Stop 5600, Washington, DC 20536-5600; email:
The Department of Homeland Security (DHS) is updating the list of STEM fields of study that fall within the regulatory definition of “STEM field.” The list, known as the DHS STEM Designated Degree Program List (“STEM list”),
In 2016, DHS published a Final Rule providing a 24-month extension of OPT for F-1 nonimmigrant students who majored in a designated STEM field of study.
OPT is one type of work permission available to certain F-1 nonimmigrant students. It allows students (except those in English language training programs) to obtain real-world work experience directly related to their field of study.
The STEM OPT extension is a 24-month extension of OPT available to F-1 nonimmigrant students who have completed 12 months of OPT and received a degree in an approved STEM field of study as designated by the STEM list.
This notice may impact qualifying F-1 nonimmigrant students who seek a 24-month extension of post-completion OPT.
The STEM list can be found in the docket for this notice and on the SEVP website.
The Secretary has broad authority to administer and enforce the nation's immigration laws.
Interested parties, including members of the public, may nominate a CIP code for inclusion on or removal from the STEM list.
Nominations to add or remove degrees from the STEM list are assessed consistent with the authorizing regulation.
As noted above, by regulation,
SEVP evaluates submissions to assess whether the degree is generally considered to be a STEM degree by recognized authorities, including input from educational institutions, governmental entities, and non-governmental entities. SEVP also reviews the NCES definition of the CIP code and any supporting material submitted by the nominator such as the required curriculum for the degree and the extent to which it is comprised of core STEM disciplines as well as research, innovation, and development of new technologies using engineering, mathematics, computer science, or natural sciences (including physical, biological, and agricultural sciences). The degree requirements and curriculum may be assessed across academic institutions to ensure that the core aspects of the degree are sufficiently consistent among educational institutions.
A proposed addition does not have to have all supporting elements to be added to the STEM list. DHS assesses the totality of a submission and may approve a proposed CIP code if it presents sufficient evidence and reasoning to establish that the regulatory definition of a STEM field encompasses the degree under consideration.
Nominations may be submitted by email to the SEVP Response Center at
The following fields of study are being added to the STEM list:
Bioenergy (03.0210).
Forestry, General (03.0501).
Forest Resources Production and Management (03.0510).
Human-Centered Technology Design (11.0105).
Cloud Computing (11.0902).
Anthrozoology (30.3401).
Climate Science (30.3501).
Earth Systems Science (30.3801).
Economics and Computer Science (30.3901).
Environmental Geosciences (30.4101).
Geobiology (30.4301).
Geography and Environmental Studies (30.4401).
Mathematical Economics (30.4901).
Mathematics and Atmospheric/Oceanic Science (30.5001).
Data Science, General (30.7001).
Data Analytics, General (30.7101).
Business Analytics (30.7102).
Data Visualization (30.7103).
Financial Analytics (30.7104).
Data Analytics, Other (30.7199).
Industrial and Organizational Psychology (42.2804).
Social Sciences, Research Methodology and Quantitative Methods (45.0102).
Eligible students are required to submit a Form I-765, “Application for Employment Authorization,” to request employment authorization and an
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Comments are encouraged and will be accepted until February 22, 2022.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be submitted via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, Telephone number (240) 721-3000 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
The information collection notice was previously published in the
The information collection instrument posted with the 60-day
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
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(7)
Office of Policy Development and Research, Chief Data Officer, Housing and Urban Development (HUD).
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Anna P. Guido, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email her at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
24 CFR 75.31 provides a number of options for certification that individuals meet the new definitions in the new final rule:
(1) For a worker to qualify as a Section 3 worker, one of the following must be maintained:
(i) A worker's self-certification that their income is below the income limit from the prior calendar year;
(ii) A worker's self-certification of participation in a means-tested program such as public housing or Section 8-assisted housing;
(iii) Certification from a PHA, or the owner or property manager of project-based Section 8-assisted housing, or the administrator of tenant-based Section 8-assisted housing that the worker is a participant in one of their programs;
(iv) An employer's certification that the worker's income from that employer is below the income limit when based on an employer's calculation of what the worker's wage rate would translate to if annualized on a full-time basis; or
(v) An employer's certification that the worker is employed by a Section 3 business concern.
(2) For a worker to qualify as a Targeted Section 3 worker, one of the following must be maintained:
(i) For a worker to qualify as a Targeted Section 3 worker for public housing financial assistance:
(A) A worker's self-certification of participation in public housing or Section 8-assisted housing programs;
(B) Certification from a PHA, or the owner or property manager of project-based Section 8-assisted housing, or the administrator of tenant-based Section 8-assisted housing that the worker is a participant in one of their programs;
(C) An employer's certification that the worker is employed by a Section 3 business concern; or
(D) A worker's certification that the worker is a YouthBuild participant.
(ii) For a worker to qualify as a Targeted Section 3 worker for a section 3 project (housing and community development financial assistance):
(A) An employer's confirmation that a worker's residence is within one mile of the work site or, if fewer than 5,000 people live within one mile of a work site, within a circle centered on the work site that is sufficient to encompass a population of 5,000 people according to the most recent U.S. Census;
(B) An employer's certification that the worker is employed by a Section 3 business concern; or
(C) A worker's self-certification that the worker is a YouthBuild participant.
These forms are designed to assist grant recipients and contractors with their recordkeeping requirements found in the regulation.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) If the information will be processed and used in a timely manner;
(3) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(4) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(5) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of Policy Development and Research, Chief Data Officer, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Anna P. Guido, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email her at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
HUD is required to develop a competitive grant program to fund nonprofit or governmental entities to provide legal assistance (including assistance related to pretrial activities, trial activities, post-trial activities and alternative dispute resolution) at no cost to eligible low-income tenants at risk of or subject to eviction. In connection with the COVID-19 emergency, the CARES Act was enacted on March 28, 2020. It placed a moratorium on eviction in all federally-assisted housing and federally-backed mortgages through July 24, 2020. The expiration of that moratorium was followed by an Order from the Centers of Disease Control and Prevention (CDC) temporarily halting evictions for nonpayment of rent on September 4, 2020, which was subsequently extended until July 31, 2021, nationally and until October 3, 2021, in areas with substantial or high levels of community transmission of COVID-19.
As households continue to struggle with income loss and accumulating back rent, the threat of evictions has grown considerably. The Household Pulse Survey Phase 3.1 found that the week of June 23, 2021, over 7.4 million renters were behind on their rent payments and another 4.9 million were not confident they would be able to make next month's payment. With the expiration of the CDC's national moratorium looming, 3.6 million renters reported eviction was likely or somewhat likely in the next two months. Housing instability caused by formal and informal evictions has significant economic, physical, and mental consequences. Research has found eviction protection services, including services such as legal representation, court navigators, education and outreach, and assistance
This notice updates HUD's previously approved emergency review request to include HUD's proposed form for collecting information about client services and outcomes. Grantees will be expected to submit this information to HUD with its post-award quarterly reports. This review is needed to fulfill Congress' intent for the Eviction Protection grant program to expeditiously provide funds to meet the need for which Congress appropriated them, reduce the harm these tenants will face without access to eviction protection services, and enable HUD to meet its statutory program monitoring and demonstration obligations for this new program.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) If the information will be processed and used in a timely manner;
(3) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(4) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(5) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Human Capital Officer, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Anna Guido, Management Analyst, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-5535 (this is not a toll-free number) or email at
Anna Guido, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410; telephone 202-402-5535, (this is not a toll-free number). Persons with hearing or speech impairments may access this number via TTY by calling the Federal Relay Service at (800) 877-8339. Copies of available documents submitted to OMB may be obtained from Anna Guido.
This notice informs the public that HUD is
The Rehabilitation Act, 29 U.S.C. 791, and Title VII of the Civil Rights Act, 42 U.S.C. 2000e, as well as Executive Orders 13164 and 14043, and 29 CFR 1605 and 1614.
Collection of information regarding medical exceptions will enable the agency to render well-informed decisions in accordance with the federal authorities. Exceptions will be granted in limited circumstances and only where legally required.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of Policy Development and Research, Chief Data Officer, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Anna P. Guido, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email her at
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) If the information will be processed and used in a timely manner;
(3) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(4) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(5) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of availability; request for comment.
We, the U.S. Fish and Wildlife Service (Service), announce the receipt and availability of an application for an incidental take permit (ITP) under the Endangered Species Act (ESA) and an associated draft low-effect habitat conservation plan (HCP). Additionally, consistent with the requirements of the National Environmental Policy Act (NEPA), we have prepared a draft low-effect screening form and environmental action statement supporting our preliminary determination that the proposed permit action qualifies for a categorical exclusion under NEPA. The Southern Nevada Water Authority has applied for an ITP under the ESA for the HCP for Warm Springs Natural Area and Hidden Valley Property in Clark County, Nevada. The ITP would authorize the take of seven species incidental to the development, construction and operation of the project. We invite the public and local, State, Tribal, and Federal agencies to comment on the permit application, proposed low-effect HCP, and NEPA categorical exclusion determination documentation. Before issuing the requested ITP, we will take into consideration any information that we receive during the public comment period.
Written comments must be received on or before February 22, 2022.
•
•
For more information, see Public Comments and Public Availability of Comments under
Glen W. Knowles, Field Supervisor, Southern Nevada Fish and Wildlife Office, by phone at 702-515-5244 or via the Federal Relay Service at 800-877-8339.
We, the Service, announce the receipt of a permit application from the Southern Nevada Water Authority (applicant), for a 15-year ITP under section 10(a)(1)(B) of the ESA, as amended (16 U.S.C. 1531
The Service's consideration of issuing an ITP also requires evaluation of its potential impacts on the natural and
Except for permitted exceptions, section 9 of the ESA (16 U.S.C. 1538
The proposed permit issuance triggers the need for compliance with the NEPA. The draft CatEx documentation was prepared to determine if issuance of an ITP, based on the draft HCP, would only have individually or cumulatively minor or negligible effects on the species covered in the HCP, as well as on other environmental values or resources, and would therefore qualify as a low-effect HCP not subject to further environmental analysis under NEPA.
Under the proposed action, the Service would issue a permit to the applicant for a period of 15 years for covered activities (described below) related to the management and restoration of the Warm Springs Natural Area (WSNA) and the Hidden Valley Property (HVP). Covered species include the federally endangered Moapa dace (
The geographic scope of this draft HCP area encompasses 7.2 stream miles (6.1 miles at WSNA and 1.1 miles at HVP) and 1,401 acres (1,250 at WSNA and 151 at HVP) Clark County, Nevada.
The proposed section 10(a) permit would allow incidental take of four covered species, one candidate for listing, from covered activities in the proposed HCP area. Two unlisted species would also be identified and addressed in the permit should they ever become listed. The applicant is requesting incidental take authorization for covered activities pertaining to the management and restoration of the WSNA and HVP, including but not limited to reconnection of channels, streams, and tributaries, bank and channel stabilization, beaver management, fish passage improvements, invasive aquatic species management, invasive plant management, clearing vegetation from streams, installation of Moapa dace habitat structures, Moapa dace snorkel surveys, fire and fuels management, pumping water for irrigation, dust control and fire suppression, operation of vehicles and maintenance equipment, general public access, property tours, field trips and school groups, neighbor outreach, volunteer planting events, and research. The applicant has also proposed spring pool restoration and enhancement, construction and enhancement of wetlands, restoration and enhancement of riparian habitat, and restoration and enhancement of mesquite and upland habitat. For each of the covered activities, the applicant has outlined best management practices in the HCP to minimize and mitigate for direct impacts to covered species. The proposed actions will result in temporary loss of habitat at the WSNA and HVP in Clark County, Nevada.
We request data, comments, new information, or suggestions from the public, other concerned governmental agencies, the scientific community, Tribes, industry, or any other interested party on the draft HCP and associated documents. If you wish to comment, you may submit comments by either of the methods in
Any comments we receive will become part of the decision record associated with this action. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can request in your comment that we withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All submissions from organizations or businesses, and from individuals identifying themselves as representatives or officials of organizations or businesses, will be made available for public disclosure in their entirety.
Issuance of a permit is a Federal proposed action subject to compliance with NEPA and section 7 of the ESA. We will evaluate the permit application, the HCP, associated documents, and any public comments we receive during the comment period to determine whether the application meets the requirements of section 10(a) of the ESA. If we determine that those requirements are met, we will conduct an intra-Service consultation under section 7 of the ESA for the Federal action and for the potential issuance of an ITP. If the intra-Service consultation confirms that issuance of the permit will not jeopardize the continued existence of any endangered or threatened species, or destroy or adversely modify critical habitat, we will issue a permit to the applicant for the incidental take of the covered species.
We provide this notice under section 10(c) of the ESA (16 U.S.C. 1539(c) and its implementing regulations (50 CFR 17.32) and NEPA (42 U.S.C. 4371
Bureau of Land Management, Interior.
Notice of intent.
In compliance with the National Environmental Policy Act of 1969 as amended (NEPA) and the Federal Land Policy and Management Act of 1976, as amended (FLPMA), the Bureau of Land Management (BLM) Southeastern States District Office, Flowood, Mississippi, intends to prepare a Resource Management Plan (RMP) Amendment to the 1995 Florida Approved RMP, with an associated Environmental Assessment (EA), to evaluate proposed future management guidance for the Jupiter Inlet Lighthouse Outstanding Natural Area (ONA). This notice announces the beginning of the scoping process to solicit public comments and identify potential issues for consideration in the EA. This notice also announces the beginning of the 30-day review of the proposed planning criteria the BLM would use in the analysis of the RMP Amendment, and calls for nominations for new proposals or modifications to the existing area of critical environmental concern (ACEC) within the Jupiter Inlet Lighthouse ONA.
Comments must be submitted in writing by February 22, 2022. The BLM will announce date(s), time(s), and detail(s) of any scoping meetings at least 15 days in advance through local news media, newspapers, social media channels, and the BLM website at:
You may submit comments on issues and planning criteria related to the Florida RMP Amendment EA by any of the following methods:
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Documents pertinent to this proposal may be examined online on the BLM ePlanning website provided above. The ePlanning site can also be accessed via links provided on the ONA official website here:
Peter DeWitt, Program Manager; telephone: (561) 295-5955; email:
The ONA was designated by Congress in 2008. It is a protected land area designation within the National Landscape Conservation System. This document provides notice that the BLM Southeastern States District intends to prepare an EA and RMP Amendment to the 1995 Florida RMP, exclusive to the ONA. The planning area is in Palm Beach County, Florida, and encompasses approximately 126 acres of both Federal and non-Federal surface lands that make up the ONA. The BLM, as directed by the Consolidated Natural Resources Act of 2008 (CNRA), manages the ONA in coordination with local partners to protect, preserve, and enhance the unique and nationally important historical, natural, cultural, scientific, educational, scenic, and recreational values at the ONA, with an emphasis on restoring native ecological systems. The proposed amendment will identify land management decisions for lands acquired within the planning area that currently have no land-use planning level decisions, evaluate land-use planning level decisions for recreation management, consider the availability of all or portions of the planning area for certain land-use authorizations, and evaluate the Jupiter Inlet tract ACEC decisions to address the need for the designation within the ONA.
The 54-acre ACEC was designated by the 1995 Florida RMP as relevant and important for wildlife and cultural resources. An ACEC Evaluation Report published in Volume 3 of the draft Southeastern States RMP/EIS on October 24, 2016, determined that the ACEC and an 83-acre expanded nomination area continue to meet the relevance and importance criteria. No further areas or configurations for ACECs applicable to the planning area have been identified from previous planning efforts or from pre-planning activities on the current land-use plan amendment effort. Both the existing ACEC and the expanded nomination area are wholly within the ONA boundaries.U.S.C
BLM identified preliminary issues for planning, which include: (1) Absence of land-use planning level guidance for the recreation and visitor services program; (2) necessity of, or lack thereof, special management for the existing ACEC or the expanded nomination area; and (3) availability of all or a portion of the ONA for issuing certain land-use authorizations. Public scoping is intended to determine relevant issues that will influence the scope of the EA, formulate alternatives, and guide the planning process.
Preliminary planning criteria include: (1) Comply with FLPMA, CNRA, and all other laws, regulations, and policies; (2) recognize valid existing rights and allow for appropriate partner uses consistent with applicable laws; (3) establish new land-use planning level guidance and identify existing guidance for managing the ONA; (4) strive to protect, conserve, and enhance the unique and nationally important values at the ONA with an emphasis on conservation; (5) provide the framework for accommodating visitors for a range of educational, interpretive, and passive recreational experiences while ensuring that the ONA is preserved; (6) remain fiscally responsible with reasonable and achievable management decisions; and (7) provide for safe facilities, infrastructure, and grounds that are compatible with achieving the resource objectives for the ONA.
You may submit comments on issues, planning criteria, the ACEC and its expanded nomination area, or new ACEC nominations in writing to the BLM at any public scoping meeting, or you may submit them to the BLM using one of the methods listed in the
The BLM will consult with Native American Tribes on a government-to-government basis in accordance with Executive Order 13175 and other policies. Tribal concerns, including potential impacts to cultural resources, will be given due consideration. Federal, State, and local agencies, along with Tribes and other stakeholders that may be interested in or affected by the proposed action that the BLM is evaluating, are invited to participate in the scoping process and, if eligible, may request to participate in the environmental analysis as a cooperating agency.
The BLM will evaluate identified issues and place them into one of three categories:
1. Issues to be resolved in the RMP Amendment,
2. Issues to be resolved through policy or administrative action, or
3. Issues beyond the scope of these plans.
The BLM will provide an explanation as to why an issue was placed in category two or three. The public is also encouraged to help identify any management questions and concerns that should be addressed in the RMP Amendment. The BLM will work collaboratively with interested parties to identify the management decisions that are best suited to local, regional, and national needs and concerns.
The BLM will use an interdisciplinary approach to develop the EA/RMP Amendment in order to consider the variety of resource issues and concerns identified. Specialists with expertise in National Conservation Lands, recreation and visitor services, archaeology, wildlife, and vegetation may be involved in the EA/RMP Amendment.
Before including your address, phone number, email address or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the National Park Service are proposing to renew an information collection with revisions.
Interested persons are invited to submit comments on or before February 22, 2022.
Written comments and suggestions on the information collection request (ICR) should be submitted by the date specified above in
To request additional information about this ICR, contact Alexis Abernathy, National Register of Historic Places, by email at
In accordance with the PRA and 5 CFR 1320.8(d)(1), we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
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As part of our continuing effort to reduce paperwork and respondent burdens, we are again soliciting comments from the public and other Federal agencies on the proposed ICR that is described below. We are especially interested in public comment addressing the following:
(1) Whether or not the collection of information is necessary for the proper performance of the functions of the agency, including whether or not the information will have practical utility.
(2) The accuracy of our estimate of the burden for this collection of information, including the validity of the methodology and assumptions used.
(3) Ways to enhance the quality, utility, and clarity of the information to be collected.
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments that you submit in response to this notice are a matter of public record. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The information collection requiring OMB approval is the requirement for property owners to submit notarized letters to the SHPO objecting to the property being listed in the National Register.
An agency may not conduct, or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Office of Natural Resources Revenue (“ONRR”), Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995 (“PRA”), ONRR is proposing to renew an information collection. Through this Information Collection Request (“ICR”), ONRR seeks renewed authority to collect information used to verify, audit, collect, and disburse royalty owed on oil, gas, and geothermal resources produced from Federal and Indian lands. ONRR uses forms ONRR-2014, ONRR-4054, and ONRR-4058 as part of these information collection requirements.
Interested persons are invited to submit written comments on or before February 22, 2022.
All comment submissions must (1) reference “OMB Control Number 1012-0004” in the subject line; (2) be sent to ONRR before the close of the comment period listed under
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To request additional information about this ICR, please contact Donna Myles, Reference & Reporting Management, ONRR, by email at
Pursuant to the PRA, 44 U.S.C. 3501,
As part of ONRR's continuing effort to reduce paperwork and respondent burdens, ONRR is inviting the public and other Federal agencies to comment on new, proposed, revised, and continuing collections of information in accordance with the PRA and 5 CFR 1320.8(d)(1). This helps ONRR to assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public to understand ONRR's information collection requirements and provide the requested data in the desired format.
ONRR is especially interested in public comments addressing the following:
(1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of ONRR's estimate of the burden for this collection of information, including the validity of the methodology and assumptions used;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) How might the agency minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
ONRR published a notice, with a 60-day public comment period soliciting comment of this collection of information, in the
Comments that you submit in response to this 30-day notice are a matter of public record. ONRR will include or summarize each comment in its request to OMB to approve this ICR. Before including your address, phone number, email address, or other personal identifying information in your
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the PRA (44 U.S.C. 3501,
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on December 15, 2021, under section 337 of the Tariff Act of 1930, as amended, on behalf of LG Electronics Inc. of Korea, and LG Electronics Alabama, Inc. of Huntsville, Alabama. A supplement was filed on December 23, 2021. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain refrigerator water filtration devices and components thereof by reason of infringement of certain claims of U.S. Patent No. 10,653,984 (“the '984 patent”); U.S. Patent No. 10,639,570 (“the '570 patent”); and U.S. Patent No. 10,188,972 (“the '972 patent”). The complaint further alleges that an industry in the United States exists as required by the applicable Federal Statute. The complainant requests that the Commission institute an investigation and, after the investigation, issue a limited exclusion order and cease and desist orders.
The complaint, except for any confidential information contained therein, may be viewed on the Commission's electronic docket (EDIS) at
Pathenia M. Proctor, The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain products identified in paragraph (2) by reason of infringement of one or more of claims 1-7 of the '984 patent; claims 1-9 of the 570 patent; and claims 1, 6, 10-13, 15, and 17-19 of the '972 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) Pursuant to section 210.10(b)(1) of the Commission's Rules of Practice and Procedure, 19 CFR 210.10(b)(1), the plain language description of the accused products or category of accused products, which defines the scope of the investigation, is “water filters for refrigerators, water filter assemblies and interconnection subassemblies for refrigerators, and water purifying apparatuses and filter structures for refrigerators”;
(3) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is:
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW, Suite 401, Washington, DC 20436; and
(4) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission,
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), as amended in 85 FR 15798 (March 19, 2020), such responses will be considered by the Commission if received not later than 20 days after the date of service by the complainants of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
United States International Trade Commission.
Notice.
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-679-680 and 731-TA-1585-1586 (Preliminary) pursuant to the Tariff Act of 1930 (“the Act”) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of sodium nitrite from India and Russia, provided for in subheading 2834.10.10 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Governments of India and Russia. Unless the Department of Commerce (“Commerce”) extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by February 28, 2022. The Commission's views must be transmitted to Commerce within five business days thereafter, or by March 7, 2022.
January 13, 2022.
Peter Stebbins ((202) 205-2039), Office of Investigations, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its internet server (
For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A and B (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).
Please note the Secretary's Office will accept only electronic filings during this time. Filings must be made through the Commission's Electronic Document Information System (EDIS,
In accordance with §§ 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
By order of the Commission.
Bureau of Alcohol, Tobacco, Firearms and Explosives, Department of Justice.
60-Day notice.
The Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), Department of Justice (DOJ), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection (IC) OMB 1140-0052 (ATF's Office of Strategic Management Environmental Assessment Outreach) is being updated to include a short purpose statement. The proposed information collection is also being published to obtain comments from the public and affected agencies.
Comments are encouraged and will be accepted for 60 days until March 22, 2022.
If you have additional comments regarding the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions, or additional information, contact: Chad Yoder, Office of Strategic Management, Director's Office, by mail at 99 New York Ave. NE, Washington, DC 20226, email at
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
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If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution
Drug Enforcement Administration, Department of Justice.
Order with opportunity for comment.
The applications for exempt chemical preparations received by the Drug Enforcement Administration between April 1, 2021, and June 30, 2021, as listed below, were accepted for filing and have been approved or denied as indicated.
Interested persons may file written comments on this order in accordance with 21 CFR 1308.23(e). Electronic comments must be submitted, and written comments must be postmarked, on or before March 22, 2022. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.
To ensure proper handling of comments, please reference “Docket No. DEA-372” on all correspondence, including any attachments.
Terrence L. Boos, Ph.D., Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-8201.
Please note that all comments received are considered part of the public record and made available for public inspection online at
If you want to submit personal identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “PERSONAL IDENTIFYING INFORMATION” in the first paragraph of your comment. You must also place all the personal identifying information you do not want posted online or made available in the public docket in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online or made available in the public docket, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment.
Comments containing personal identifying information and confidential business information identified as directed above will generally be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this document is available at
Section 201 of the Controlled Substances Act (CSA) (21 U.S.C. 811) authorizes the Attorney General, by regulation, to exempt from certain provisions of the CSA certain compounds, mixtures, or preparations containing a controlled substance, if he finds that such compounds, mixtures, or preparations meet the requirements detailed in 21 U.S.C. 811(g)(3)(B).
The Assistant Administrator received applications between April 1, 2021, and June 30, 2021, requesting exempt chemical preparation status detailed in 21 CFR 1308.23. Pursuant to the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23, the Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart I below is intended for laboratory, industrial, educational, or special research purposes and not for general administration to a human being or animal and either: (1) Contains no narcotic controlled substance and is packaged in such a form or concentration that the packaged quantity does not present any significant potential for abuse; or (2) contains either a narcotic or non-narcotic controlled substance and one or more adulterating or denaturing agents in such a manner, combination, quantity, proportion, or concentration that the preparation or mixture does not present any potential for abuse and, if the preparation or mixture contains a narcotic controlled substance, is formulated in such a manner that it incorporates methods of denaturing or other means so that the preparation or
Accordingly, pursuant to 21 U.S.C. 811(g)(3)(B), 21 CFR 1308.23, and 21 CFR 1308.24, the Assistant Administrator has determined that each of the chemical preparations or mixtures generally described in Chart I below and specifically described in the application materials received by DEA is exempt, to the extent described in 21 CFR 1308.24, from application of sections 302, 303, 305, 306, 307, 308, 309, 1002, 1003, and 1004 (21 U.S.C. 822-823, 825-829, and 952-954) of the CSA, and 21 CFR 1301.74, as of the date that was provided in the approval letters to the individual requesters.
The exemptions are applicable only to the precise preparation or mixture described in the application submitted to DEA in the form(s) listed in this order and only for those above mentioned sections of the CSA and the CFR. In accordance with 21 CFR 1308.24(h), any change in the quantitative or qualitative composition of the preparation or mixture, or change in the trade name or other designation of the preparation or mixture after the date of application requires a new application. The requirements set forth in 21 CFR 1308.24(b)-(e) apply to the exempted materials. In accordance with 21 CFR 1308.24(g), DEA may prescribe requirements other than those set forth in 21 CFR 1308.24(b)-(e) on a case-by-case basis for materials exempted in bulk quantities. Accordingly, in order to limit opportunity for diversion from the larger bulk quantities, DEA has determined that each of the exempted bulk products listed in this order may only be used in-house by the manufacturer, and may not be distributed for any purpose, or transported to other facilities.
Additional exempt chemical preparation requests received between April 1, 2021, and June 30, 2021, and not otherwise referenced in this order, may remain under consideration until DEA receives additional information required, pursuant to 21 CFR 1308.23(d), as detailed in separate correspondence to individual requesters. DEA's order on such requests will be communicated to the public in a future
DEA also notes that these exemptions are limited to exemption from only those sections of the CSA and the CFR that are specifically identified in 21 CFR 1308.24(a). All other requirements of the CSA and the CFR apply, including registration as an importer as required by 21 U.S.C. 957.
The Assistant Administrator has found that each of the compounds, mixtures, and preparations described in Chart II below is not consistent with the criteria stated in 21 U.S.C. 811(g)(3)(B) and in 21 CFR 1308.23. Accordingly, the Assistant Administrator has determined that the chemical preparations or mixtures generally described in Chart II below and specifically described in the application materials received by DEA, are not exempt from application of any part of the CSA or from application of any part of the CFR, with regard to the requested exemption pursuant to 21 CFR 1308.23, as of the date that was provided in the determination letters to the individual requesters.
Pursuant to 21 CFR 1308.23(e), any interested person may submit written comments on or objections to any chemical preparation in this order that has been approved or denied as exempt. If any comments or objections raise significant issues regarding any finding of fact or conclusion of law upon which this order is based, the Assistant Administrator will immediately suspend the effectiveness of any applicable part of this order until he may reconsider the application in light of the comments and objections filed. Thereafter, the Assistant Administrator shall reinstate, revoke, or amend his original order as he determines appropriate.
A list of all current exemptions, including those listed in this order, is available on the DEA's website at
On June 7, 2021, a former Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause to Daniel R. Nevarre, M.D., (hereinafter, Applicant), of South Jordan, Utah. Order to Show Cause (hereinafter, OSC), at 1. The OSC proposed the denial of Applicant's application No. H21079595C for a DEA Certificate of Registration, because the United States Department of Health and Human Services, Office of Inspector General (hereinafter, HHS/OIG) mandatorily excluded Applicant from participation in Medicare, Medicaid, and all Federal health care programs for a minimum period of 10 years pursuant to 42 U.S.C. 1320a-7(a); and such exclusion “warrants denial of [Applicant's] application for DEA registration pursuant to 21 U.S.C. 824(a)(5).”
The OSC alleged that on May 25, 2018, Applicant “pled guilty to one count of medical assistance fraud in violation of 62 P.S. § 1407(a)(1), and to one count of insurance fraud, in violation of 18 Pa.C.S. § 4117(a)(2).”
The OSC also proposed denial of Applicant's application based on 21 U.S.C. 824(a)(1), because Applicant responded “no” to Liability Question 1 on his DEA application, which asks whether Applicant has ever been excluded from participation in a medicare program.
The Show Cause Order notified Applicant of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option.
In a signed and sworn Declaration, a Diversion Investigator (hereinafter, DI 2) assigned to the Pittsburg District Office, Philadelphia Field Division, stated that, on June 21, 2021, after receiving a request from the Salt Lake City District Office to assist with service of the OSC, he and a Narcotics Agent from the Pennsylvania Office of the Attorney General traveled to Applicant's residential address in Johnstown, Pennsylvania, where he “personally served [the Applicant] with a copy of the [OSC].” Request for Final Agency Action, dated November 9, 2021 (hereinafter, RFAA), Exhibit (hereinafter, RFAAX) 3 (DI 2 Declaration), at 1-2.
The Government forwarded its RFAA, along with the evidentiary record, to this office on November 9, 2021. In its RFAA, the Government represents that “neither [Applicant] nor any attorney representing [Applicant] has requested a hearing” or filed a written statement. RFAA, at 2;
Based on the DI's Declaration, the Government's written representations, and my review of the record, I find that the Government accomplished service of the OSC on Applicant on June 21, 2021. I also find that more than thirty days have now passed since the Government accomplished service of the OSC. Further, based on the Government's written representations, I find that neither Applicant, nor anyone purporting to represent the Applicant, requested a hearing, submitted a written statement while waiving Applicant's right to a hearing, or submitted a corrective action plan. Accordingly, I find that Applicant has waived the right to a hearing and the right to submit a written statement and corrective action plan. 21 CFR 1301.43(d) and 21 U.S.C. 824(c)(2)(C). I, therefore, issue this Decision and Order based on the record submitted by the Government, which constitutes the entire record before me. 21 CFR 1301.43(e).
On February 1, 2021, DEA received an application from Applicant for a DEA Certificate of Registration as a practitioner in Schedules IIN
DI 1 submitted a Declaration, dated September 13, 2021, which stated that Applicant had previously surrendered for cause DEA Certificates of Registration numbered FN7029487 and BN5130290 on September 5, 2018, and October 15, 2018, respectively, after losing his state authority to practice medicine in Pennsylvania. RFAAX 1 (DI 1 Declaration) at 2. DI 1 further stated that Applicant's third previous DEA Certificate of Registration numbered FN5716420 in New York expired on October 31, 2018.
The Government's uncontroverted evidence demonstrates that Applicant pled guilty to false information/claims and insurance fraud on or about May 25, 2018, in the Court of County Pleas in Cambria County, Pennsylvania. RFAAX 1, at App. C (Applicant's Guilty plea). In a letter from the HHS/OIG, dated October 31, 2018, HHS excluded Applicant from Medicare, Medicaid, and all federal health care programs under 42 U.S.C. 1320a-7(a) for a minimum period 10 years based on Applicant's conviction. RFAAX 1, App. E (hereinafter, HHS Exclusion), at 1. The HHS Exclusion stated that the exclusion would become effective twenty days from the date of the letter.
Accordingly, I find clear, unequivocal, and convincing record evidence that HHS excluded Applicant from Medicare, Medicaid, and all federal health care programs under 42 U.S.C. 1320a-7(a) for a minimum of 10 years, effective November 20, 2018.
I find clear, unequivocal, and convincing record evidence that Applicant answered “N” to the first Liability question on the registration renewal application that was received by DEA on or about February 1, 2021. RFAAX 1, App. 1, at 2. I find clear, unequivocal, and convincing record evidence that the text of the first Liability question on the registration renewal application that Applicant submitted on or about February 1, 2021, asked whether Applicant had “ever been . . . excluded or directed to be excluded from participation in a medicare or state health care program, or is any such action pending.”
In its OSC, the Government relied upon grounds Congress provided to support revocation/suspension, not denial of an application. Prior Agency decisions have addressed whether it is appropriate to consider a provision of 21 U.S.C. 824(a) when determining whether or not to grant a practitioner registration application. For over forty-five years, Agency decisions have concluded that it is.
Accordingly, when considering an application for a registration, I will consider any actionable allegations related to the grounds for denial of an application under 823 and will also consider any allegations that the applicant meets one or more of the five grounds for revocation or suspension of a registration under section 824.
Pursuant to section 303(f) of the Controlled Substances Act (hereinafter, the CSA), “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Section 303(f) further provides that an application for a practitioner's registration may be denied upon a determination that “the issuance of such registration . . . would be inconsistent with the public interest.”
In this case, there is no indication that Applicant does not hold a valid state medical license or is not authorized to dispense controlled substances in the State of Utah, where he has applied for a registration.
Because the Government has not alleged that Applicant's registration is inconsistent with the public interest under section 823, and although I have considered 823, I will not analyze Applicant's application under the public interest factors. Therefore, in accordance with prior agency decisions, I will move to assess whether the Government has proven by substantial evidence that a ground for revocation exists under 21 U.S.C. 824(a).
Under Section 824(a) of the CSA, a registration “may be suspended or revoked” upon a finding of one or more of five grounds. 21 U.S.C. 824. The ground in 21 U.S.C. 824(a)(5) requires that the registrant “has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42.”
As already discussed, I find clear, unequivocal, and convincing evidence that Applicant submitted a registration application containing a false answer to the first Liability question.
I find that there is clear, convincing, and unequivocal evidence in the record supporting denial of Applicant's application based on his having “materially falsified any application filed pursuant to or required by this subchapter or subchapter II.” 21 U.S.C. 824(a)(1).
Where, in section 824(a)(5) cases, the applicant offers no mitigating evidence upon which the Administrator can analyze the facts, the agency has consistently held that revocation/suspension/denial is warranted.
Accordingly, I find that there is clear, convincing, and unequivocal evidence in the record supporting denial of Applicant's application based on his exclusion from federal health care programs. 21 U.S.C. 824(a)(5). I further
Here, there is no dispute in the record that Applicant is mandatorily excluded pursuant to Section 1320a-7(a) of Title 42, and, further that Applicant materially falsified his application for a controlled substance registration, and therefore, that grounds for the denial of Applicant's application exist. Where, as here, the Government has met its
In this case, Applicant failed to respond to the Government's Order to Show Cause and did not avail himself of the opportunity to refute the Government's case.
Consequently, I find that the factors weigh in favor of sanction and I shall order the sanctions the Government requested, as contained in the Order below.
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f) and 21 U.S.C. 824(a), I hereby deny the pending application for a Certificate of Registration, Control Number H21079595C, submitted by Daniel R. Nevarre, M.D., as well as any other pending application of Daniel R. Nevarre, M.D. for additional registration in Utah. This Order is effective [insert Date Thirty Days From the Date of Publication in the
On October 22, 2020, a former Assistant Administrator, Diversion Control Division, of the Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Stephen E. Owusu, D.P.M. (hereinafter, Respondent) of Brooklyn, New York. Administrative Law Judge Exhibit (hereinafter, ALJX) 1 (OSC), at 1. The OSC proposed the denial of Respondent's application for DEA Certificate of Registration No. W19061136C (hereinafter, COR or registration) and the denial of any applications for any other DEA registrations pursuant to 21 U.S.C. 824(a)(2) and 824(a)(5) because Respondent was convicted of a felony related to controlled substances and because Respondent has been excluded from participation in Medicare, Medicaid, and all federal health care programs pursuant to 42 U.S.C. 1320a-7(a).
On November 23, 2020, the Respondent timely requested a hearing, which commenced (and ended) on February 17, 2021, at the DEA Hearing Facility in Arlington, Virginia with the parties, counsel, and witnesses participating via video teleconference (VTC). On April 9, 2021, Administrative Law Judge Teresa A. Wallbaum (hereinafter, the ALJ) issued her Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (hereinafter, Recommended Decision or RD). By letter dated May 4, 2021, the ALJ certified and transmitted the record to me for final Agency action. In the letter, the ALJ advised that neither party filed exceptions. Having reviewed the entire record, I adopt the ALJ's rulings, findings of fact, as modified, conclusions of law and recommended sanction with minor modifications, where noted herein.*
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The issue to be ultimately decided by the Acting Administrator, with the assistance of this Recommended Decision, is whether Respondent's application should be denied based
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions of law below.
The Government alleges that the denial of Respondent's application is supported by incontrovertible record evidence that he has been both convicted of a felony related to controlled substances and excluded from participation in a federal health care program. ALJ Ex. 1. The Government further alleges that judgment was entered against Respondent in the United States District Court for the Eastern District of New York after pleading guilty to one count of Conspiracy to Distribute Oxycodone, a Class C Felony, in violation of 21 U.S.C. 841(a), (b)(1)(C), and 846.
The following stipulations were mutually agreed upon by the parties and are conclusively accepted as fact in these proceedings:
1. On or about June 12, 2019, Respondent filed with the DEA an application for registration as a practitioner in Schedules II through V pursuant to DEA control number W19061136C, with a proposed registered address of 106 Pennsylvania Ave., Suite 1, Brooklyn, NY 11207-2427.
2. On or about July 19, 2011, Respondent surrendered for cause his previous DEA registration, No. BO3613331.
3. On June 13, 2017, Judgment was entered against Respondent in the United States District Court for the Eastern District of New York after Respondent pleaded guilty to one count of “Conspiracy to Distribute Oxycodone, a Class C Felony,” in violation of 21 U.S.C. 841(a), (b)(1)(C), and 846.
4. Based on Respondent's conviction, the New York State Office of the Medicaid Inspector General excluded Respondent from participation in the New York Medicaid program. The exclusion was effective August 30, 2017.
5. Based on Respondent's conviction, the U.S. Department of Health and Human Services, Office of Inspector General (HHS/OIG), mandatorily excluded Respondent from participation in Medicare, Medicaid, and all federal health care programs pursuant to 42 U.S.C. 1320a-7(a). The exclusion was effective on October 19, 2017, and runs for a period of five years.
6. Reinstatement of eligibility to participate in Medicare, Medicaid, and all federal health care programs after exclusion by HHS/OIG is not automatic.
7. Respondent is currently excluded from participation in Medicare, Medicaid, and all federal health care programs.
The Government's case-in-chief consisted of the testimony of a single witness, a DEA Diversion Group Supervisor (hereinafter, the GS). The GS testified that her duty station is the New York Field Division, located in New York City, where she has served in her capacity as a group supervisor for approximately one year. Tr. 21-22. Before the GS was promoted to group supervisor, she worked as a Diversion Investigator for approximately 24 Years. Tr. 22. In her position as a group supervisor, the GS is required to undergo periodic training as a part of her duties. Tr. 23. Further, she has been involved in over 200 DEA investigations throughout her career.
Respondent came to the attention of the GS when she was assigned his application for DEA registration. Tr. 24. The GS also testified that she interviewed Respondent on two occasions.
The parties agree, and the evidence demonstrates, that, on June 13, 2017, Respondent pleaded guilty to one count of Conspiracy to Distribute Oxycodone, a Class C Felony, in violation of 21 U.S.C. 841(a), (b)(1)(C), and 846. Gov. Ex. 5, 6.
Respondent's exclusion from Medicare, Medicaid, and all federal health care programs, along with Respondent's conviction of Conspiracy to Distribute Oxycodone, are the bases of the Government's present case opposing Respondent's application for a new COR. The GS testified that, on February 16, 2021, she ran a new search on a web page of the U.S. Department of Health and Human Services, Office of Inspector General, and confirmed through that search that Respondent was still excluded from all federal health care programs. Tr. 43.
The GS came across as an objective investigator, with no discernable motive to mislead, fabricate, or exaggerate. The testimony of this witness was primarily focused on the uncontroversial
Respondent, proceeding
Respondent has worked both as a solo practitioner and a clinic physician, specializing in wound care at two different clinics. Tr. 54; 57-59. In one of those clinics, Respondent served as the director, specializing in baric neuropathy, supervising three to four nurses and nurse practitioners, and seeing 50 patients a day. Tr. 54-56. For nearly ten years, starting in 1998, he also worked in a dialysis clinic specializing in treating patients in “end-stage renal dialysis” who suffered lower extremity problems. Tr. 61-63.
Respondent testified that, prior to 2011, he never had any disciplinary problems in either New York or Pennsylvania and had no arrests or convictions. Tr. 60; 64; 87.
Respondent admitted that he pleaded guilty to one count of Conspiracy to Distribute Oxycodone on June 13, 2017, in violation of 21 U.S.C. 841(a), (b)(1)(C), and 846. Stip. 3;
During the hearing, Respondent testified that he had prescribed oxycodone for one patient (who had been referred to him by another, trusted patient) on the patient's third visit. Tr. 67-70. Specifically, he prescribed the oxycodone because the patient had brought oxycodone in with him, told the Respondent he had taken it from his brother, and it was the only medication that reduced his pain. Tr. 69-70. Respondent refilled the oxycodone prescription approximately once a month or once every two months for two years. Tr. 74. The same patient brought in a couple of friends on the same construction site where he worked and Respondent likewise prescribed those patients oxycodone. Tr. 75. Respondent explained that he prescribed oxycodone because he was “very naïve” and sometimes “too helpful” or “too kind.” Tr. 64 and 76.
He also testified that two prescription pads were lost from his office and “a lot of guys” had come to the pharmacy and written prescriptions from his pad. Tr. 76. According to Respondent, someone from the pharmacy would have testified for him. Tr. 76; Tr. 108. Respondent's lawyers, however, declined to investigate his defense and DEA produced only 20 of the 200 it alleged were illegal. Tr. 108-109;
On cross-examination, Respondent admitted that, on one occasion, he delivered multiple oxycodone prescriptions to a patient in a parking lot at 8:30 p.m. or 9:00 p.m. Tr. 113-115. He did so “from the kindness of [his] heart” because the patient was taking his son to a football practice or game and could not make it to the medical office in time. Tr. 109-110. At the time, Respondent did not realize it was a “setup,” and that it was “staged.”
Respondent insisted that he charged the patient $70, even though the patient paid him $300 for the prescriptions, and testified that “why [the patient] gave [him] $300, [he doesn't] know.” Tr. 115. When interviewed by DEA agents, he admitted that he made approximately $30,000 over the course of two years for these patients. Tr. 111-112. He viewed the cash payment in the parking lot as “almost like a technicality” because the patient would have paid him the same amount had he come into the office. Tr. 126.
When asked whether he had examined his patients before prescribing, Respondent provided an evasive answer:
Q: Dr. Owusu, isn't it true that you issued multiple prescriptions for oxycodone without examining the patients?
A: I examined them, Your Honor. Counsellor, I examined them.
Q: All of them?
A: Well, the—the initial—the initial patients, all of them were examined.
Respondent emphasized that he was hesitant to explain his prior convictions because he did not “want it to be misconstrued as a lack of penitence and a lack of repentance.” Tr. 50;
Rather, Respondent claimed that he was forced, and indeed tricked, into pleading guilty by his lawyers.
Respondent admitted that he was guilty, but just for the “two prescriptions I wrote . . . . [T]hat's what . . . my guilt is about.” Tr. 80. He acknowledged that he had appeared
Indeed, Respondent often cast himself as the victim—repeatedly stating that he “suffered” because of the conviction. For example, after recounting the facts behind his conviction, Respondent stated: “They were the things I have suffered in the past, okay? Some of the things I look back on, and I—I've suffered for the last ten years because.” Tr. 132;
According to Respondent, he has not earned his living from the practice of medicine since his arrest, since it is impossible to practice without a DEA registration. Tr. 61; Tr. 82-83. He admitted, however, that it was possible to practice without a DEA registration, although such practice would be limited. Tr. 119-121.
As for remedial measures, Respondent testified that he had taken four classes regarding opioid addiction—one in September 2011, one in 2019, one in July 2020, and one in February 2021. Tr. 83-86.
Finally, Respondent submitted a letter from Dr. B.-A. (doctor of Public Administration) regarding Respondent's current work at his clinic supporting his character. Resp't Ex. 2; Tr. 96; 123.
As noted in more detail in the Analysis section,
The Government offered one rebuttal witness—a Special Agent of the Drug Enforcement Administration (hereinafter, the SA). The SA testified that he is assigned to the Long Island District Office in Central Islip, New York. Tr. 138. The Special Agent also testified that he has been a Special Agent with DEA since 1996, and that his job duties include conducting investigations, some of which are undercover. Tr. 139. In approximately 2011, The Special Agent became familiar with Respondent during an investigation involving oxycodone distribution. Tr. 139-140. During that investigation, Respondent was identified and arrested. Tr. 140.
An individual named B. C.—a patient of Dr. Owusu's—cooperated with the Government in this 2011 investigation.
The SA, relying upon a post-arrest report, testified that Respondent had issued numerous prescriptions during the recorded transaction with B.C., but that the report did not specify how many.
The SA testified that, after his arrest, Respondent stated that he did conduct a physical examination of B.C. before selling the prescription narcotics, but that, once confronted with the video of the transaction, Respondent admitted that was a lie—that, in fact, no examination was conducted—and apologized for lying.
On cross-examination, the SA testified that he recalled seeing the meeting between Respondent and B.C. Tr. 149. He also testified that he was not sure if he ever had to move his vehicle to get a better view of the transaction, and he could not remember if his view was obstructed at any time.
The SA came across as an objective investigator, with no discernible motive to mislead, fabricate, or exaggerate. Though at times, the SA did struggle to remember certain details, he readily admitted what he did not remember, and when his recollection was refreshed, his testimony was sufficiently detailed, plausible, and internally consistent to be afforded full credibility.
The Government opposes Respondent's COR application under the dual bases that he has been convicted of a controlled-substance-related felony and that he has been excluded from participating in a specified federal health care program. ALJ Ex. 1.*
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Accordingly, when considering an application for a registration, I will consider any actionable allegations related to the grounds for denial of an application under 823 and will also consider any allegations that the applicant meets one of the five grounds for revocation or suspension of a registration under section 824.
Pursuant to section 303(f) of the CSA, “[t]he Attorney General shall register practitioners . . . to dispense . . . controlled substances . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Section 303(f) further provides that an application for a practitioner's registration may be denied upon a determination that “the issuance of such registration . . . would be inconsistent with the public interest.”
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
In this case, it is undisputed that Respondent holds a valid state medical license and is authorized to dispense controlled substances in the State of New York where he practices.
Because the Government has not alleged that Respondent's registration is inconsistent with the public interest under section 823, and although I have considered 823, I will not analyze Respondent's application under the public interest factors. Therefore, in accordance with prior agency decisions, I will move to assess whether the Government has proven by substantial evidence that a ground for revocation exists under 21 U.S.C. 824(a).]
Regarding the two revocation/suspension grounds the Government specifically relied on in this case, the CSA, in pertinent part, states the following:
A registration pursuant to section 824 of this title to . . . dispense a controlled substance . . . may be suspended or revoked by the Attorney General upon a finding that the registrant:
(2) has been convicted of a felony under this subchapter or subchapter II or any other law of the United States, or of any State, relating to any substance defined in this subchapter as a controlled substance . . . [or]
(5) has been excluded (or directed to be excluded) from participation in a program pursuant to section 1320a-7(a) of Title 42.
The Government seeks denial of Respondent's COR application under 21 U.S.C. 824(a)(5) because he has been excluded from participation in a federal health care program (Mandatory Medicare Exclusion or MME). [The Agency has] discretion to deny a respondent's application for a COR if Respondent “has been excluded (or directed to be excluded) from participation in a program pursuant to [42 U.S.C. 1320a-7(a)].” 21 U.S.C. 824(a)(5) (2012).
Specifically, subsection (a) of § 1320a-7, the part of the statute referenced by 21 U.S.C. 824(a)(5), dictates when HHS is required to exclude individuals or entities.
When DEA alleges that a practitioner has been mandatorily excluded from a federal health care program under 42 U.S.C. 1320a-7a, and thus seeks to impose a COR sanction, the Government bears the burden to prove that such an exclusion occurred.
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The Government also alleges that Respondent's application should be denied because he has been convicted of a felony related to controlled substances, pursuant to 21 U.S.C. 824(a)(2). Under that provision, the Attorney General
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Inasmuch as Congress has determined that a mandatory health care program exclusion constitutes an adequate basis for sanction, once the Government has demonstrated that a respondent has been so excluded, the burden shifts to the respondent to show that registration should be granted as a matter of discretion.
In
Further, the Agency has stated that “ordinarily[,] a respondent who has been convicted of a felony subject to § 824(a)(2) is entitled to present a case as to why his registration should not be revoked (or his application denied)” because conviction of a felony under the CSA is not a
There can be no debate that the Government has met its
The purpose of this process is to determine whether the applicant can and should be entrusted with responsibly discharging the life and death duties of a DEA registrant. For this purpose, acceptance of responsibility is critical. The Agency's interpretation of its statutory mandate on the exercise of its discretionary function under the CSA has been sustained on review.
To avoid sanction, it is incumbent upon Respondent to demonstrate acceptance of responsibility for his actions and remedial measures taken, and Respondent fails to persuade the tribunal that granting his application for a COR would be consistent with the public interest. To begin, Respondent's testimony was not candid. Candor to the court is of paramount importance. The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual respondent; therefore, the Agency looks at factors, such as the acceptance of responsibility and the credibility of that acceptance as it relates to the probability of repeat violations. A registrant's candor during the investigation and hearing is an important factor in determining acceptance of responsibility and the appropriate sanction; as is whether the registrant's acceptance of responsibility is unequivocal.
Moreover, throughout his testimony, Respondent had ample opportunity to take full and unequivocal responsibility for his misconduct. Yet repeatedly, when pressed on the details of his conviction, Respondent failed to do so, often deflecting blame to his lawyers, who, he says, forced him to accept a plea deal. Tr. 76-80; 116; ALJ Ex. 14 at 2 (referring to “unscrupulous lawyers whose solutions were worse than the problem”). This refusal to accept blame is compounded by the inescapable conclusion that Respondent's testimony was not credible on the key facts surrounding his federal conviction for conspiracy to distribute oxycodone. For example, when asked about the surrender of his previous DEA registration, Respondent made a point to “clarify” by stating, “I pleaded guilty . . . that I wrote those medications. I wrote them without . . . an attending. But all those conspiratorial charges that they added on, no. . . . [I]n the . . . two pads I wrote—the two prescriptions I wrote, I pleaded guilty for that. . . . [T]hat's what . . . my guilt is about.” Tr. 80. This is far from true. As outlined by the stipulations in these proceedings, Respondent pleaded guilty in federal court to Conspiracy to Distribute Oxycodone. Stip. 3. Although part of the indictment against him included allegations that Respondent had left prescription pads unattended, and those pads ended up the source of falsified prescriptions, Respondent's guilt is about much more than that. Respondent was arrested after an undercover operation, detailed by the testimony of the SA. Tr. 138-155. This transaction amounted to an illegal sale of narcotics and had nothing to do with Respondent's lost prescription pads. Respondent's attempt, therefore, to direct focus in these proceedings to the lost pads, rather than the sale of oxycodone prescriptions in a parking lot, amounts to a failure to accept responsibility for the entirety of his criminal conduct. As if that were not a poor enough reflection of his credibility, Respondent repeatedly and explicitly insisted that he never conspired to distribute oxycodone—the very conduct to which he pleaded guilty before a federal judge. Tr. 64-66; 78; 116; 125; ALJ 14 at 5.
Respondent's failure to acknowledge the full scope of his criminal liability presents a more significant problem—although Respondent admitted that he had appeared before a federal district
Indeed, Respondent testified in this hearing that his attorney told him to just “follow his orders” and “made [him] plead guilty.” Tr. 79. Even more disturbing, Respondent testified that he had to say yes because “my lawyer told me to just say yes—yes, yes, and I—and I went all along like that.” Tr. 80. Later, in these proceedings, Respondent admitted that his statements under oath at his plea hearing, before a federal district court judge, were “not only just not true . . . I just didn't feel like a lot of them were right.” Tr. 134.
Respondent's claims that he was forced or tricked into pleading guilty are simply not believable. Respondent's late-night delivery of
Ultimately, this tribunal cannot ignore that Respondent has changed his version of events—under oath—in two different judicial proceedings. By pleading guilty, Respondent obtained a benefit of acceptance of responsibility and, ultimately, a sentence of probation despite facing a Guideline Sentence of 57 to 71 months. Tr. 130; Govt Ex. 5. Before this tribunal, when faced with the consequences of that plea, Respondent repeatedly proclaimed his innocence of the conspiracy to distribute oxycodone, minimizing his involvement to two prescriptions. Tr. 64-66, 80, 125; ALJ Ex. 14. It is hard to see how Respondent's testimony in this tribunal, when held up against his plea agreement, amounts to anything more than Respondent's attempt to have his proverbial cake and eat it too. His guilty plea in federal court saved him from significant prison time. But now, when faced with the consequences of that plea, he has changed the story in an effort to obtain a DEA registration. Either he was dishonest in federal court, or he was dishonest in these proceedings. Either way, Respondent was dishonest and has failed to accept full responsibility for his actions.
Other implausible aspects of Respondent's testimony certainly do not assist his request for a COR as they demonstrate a lack of candor. For example, Respondent's first instinct when speaking with DEA was to lie about whether he had performed an evaluation of the patient in the car—retracting that statement only when confronted with the existence of a video-recording and apologizing to DEA for his lie. Tr. 145. Significantly, Respondent's lie demonstrated clear consciousness of guilt—he stated he had examined his patient because he knew delivering prescriptions at night in a parking lot was wrong. Similarly unbelievable is Respondent's statement that he only charged his patient $70 for the parking lot prescriptions and had no idea why he was given $300 in cash. Tr. 115. This statement is inconsistent with the post-arrest statement, in which he admitted that he charged his patients $300 for the prescriptions. Tr. 142. Nor is it plausible that a pharmacy representative would have testified that multiple people filled out Respondent's prescription pads in front of pharmacy staff (Tr. 76, 108)—activity that would certainly have imperiled the pharmacy's DEA registration.
All these inconsistencies are accompanied by a final troubling truth about Respondent's testimony: In the end, he saw himself as a victim. Respondent consistently referred to the undercover operation resulting in his arrest as “staged” or a “set-up.” Tr. 109-110, 113-115. Additionally, Respondent repeatedly contended that he had “suffered a lot” (Tr. 161) and had been “punished enough.” Tr. 105, 163; ALJ Ex. 12 at 3 (“I will acknowledge that the length of my punishment has been excessive and therefore demands a judicial reprieve.”); ALJ Ex. 14 at 4-5 (describing the “windfall repercussions from this catastrophe. . . .”). In his Supplemental Prehearing Statement, he even asked, “How much more damage/harm do you suppose is enough to satisfy/pacify the arm of the law?” ALJ Ex 14 at 3. And when Respondent claimed that he had accepted responsibility for his misconduct, he did so only with a caveat that his lawyers forced him to plead guilty. Tr. 161-62 (claiming that he accepts responsibility even though that some things in the Government's criminal case against him “were not true”). This conditional acceptance of responsibility is a far cry from
Having concluded that Respondent has failed to prove an unequivocal acceptance of responsibility, I need not address remedial measures.
The burden is on the respondent to present sufficient evidence of his remedial measures.
Respondent claims that, prior to his arrest, he had “no idea” of the severity of the opioid epidemic. Tr. 83. He testified that he attended a mandatory class on opioids, which every prescriber must take. Tr. 84. Respondent also testified that he would take another class on February 28, 2021, but he did not provide any level of detail as to the
To begin, it is of course troubling that a medical professional with a COR would not appreciate the severity of the opioid drug crisis in this country.
Overall, as Respondent faces the hurdle of demonstrating an adequate acceptance of responsibility, his testimony was just not credible. Certainly, it would strain all bounds of reasonable jurisprudence to find that Respondent has accepted responsibility for his actions, despite his trivialization of his misconduct, his disavowal of his statements under oath in his plea hearing in federal district court, his implausible testimony, and his own view of himself as a victim.
In any event, given the limited scope of Respondent's remedial measures, those measures do not change the outcome. His limited efforts do not establish a plan of remedial measures that assure the tribunal that he will not repeat the established transgressions.
Although he testified that he has taken several classes on the opioid epidemic, Respondent provided no information about these classes. Nor does completion of one mandatory class per year tend to show that Respondent has taken sufficient remedial measures to address his past misconduct—or to even appreciate the egregiousness of this conduct. While Respondent claimed that he was naïve (Tr. 55, 76), and did not appreciate the full extent of the pandemic, he failed to articulate what specific steps he would take to ensure that his misconduct resulting in diversion would not be repeated.
Accordingly, I find that, in the face of the Government's
In determining whether and to what extent imposing a sanction is appropriate, consideration must be given to the Agency's interest in both specific and general deterrence as well as the egregiousness of the offenses established by the Government's evidence.
With respect to specific deterrence, Respondent failed in these proceedings to portray a registrant who is remorseful, and who has worked hard to change for the better. Rather, Respondent came across as a person who says the right thing in order to get what he wants, and, when pressed, does not own up to his mistakes. Without a better indication of remorse, the tribunal can only conclude that granting Respondent a COR would put the public at risk of Respondent's previous diversionary behavior. Moreover, with respect to general deterrence, the Agency bears the responsibility to deter conduct similar to Respondent's past misconduct.
Finally, this tribunal finds that Dr. Owusu's behavior was egregious. Dr. Owusu conducted a transaction that differs in no material respect from a drug deal. He sold multiple
Accordingly, it is herein respectfully recommended that Respondent's application for a DEA registration be
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny the pending application for a Certificate of Registration, Control Number W19061136C, submitted by Stephen E. Owusu, D.P.M., as well as any other pending application of Stephen E. Owusu, D.P.M., for additional registration in New York. This Order is effective February 22, 2022.
On August 11, 2021, the Acting Assistant Administrator, Diversion Control Division, Drug Enforcement Administration (hereinafter, DEA or Government), issued an Order to Show Cause (hereinafter, OSC) to Alex E. Torres, M.D. (hereinafter, Respondent) of San Diego, California. OSC, at 1 and 3. The OSC proposed the revocation of Respondent's Certificate of Registration No. BT1734943.
Specifically, the OSC alleged that on March 18, 2021, Respondent entered into a Stipulated Surrender of License and Order (hereinafter, Stipulated Surrender) with the Medical Board of California (hereinafter, the Board) “whereby [Respondent] agreed to surrender [his] California state medical license.”
The OSC notified Respondent of the right to request a hearing on the allegations or to submit a written statement, while waiving the right to a hearing, the procedures for electing each option, and the consequences for failing to elect either option.
By letter dated October 12, 2021, Respondent timely requested a hearing.
The Office of Administrative Law Judges put the matter on the docket and assigned it to Administrative Law Judge Paul E. Soeffing (hereinafter, the ALJ). The ALJ issued the Briefing Schedule on October 13, 2021. On October 21, 2021, the Government timely filed its Notice of Filing of Evidence and Motion for Summary Disposition (hereinafter, Government's Motion). Order Granting the Government's Motion for Summary Disposition, and Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision of the Administrative Law Judge (hereinafter, Recommended Decision or RD), at 2. In its Motion, the Government “request[ed] summary disposition and a recommendation that Respondent's DEA Certificate of Registration as a practitioner be revoked based on his lack of authority to handle controlled substances in the State of California, the state in which he is registered with the DEA.” Government's Motion, at 5. Respondent did not answer the Government's Motion.
The ALJ issued his Recommended Decision on November 2, 2021, granting the Government's Motion and finding that “[a]s the Respondent does not have authority as a practitioner in California, there is no other fact of consequence for [the] tribunal to decide in order to determine whether or not he is entitled to hold a [DEA registration].” RD, at 6. Further, the ALJ recommended that Respondent's DEA registration be revoked and that any application to renew or modify his registration and any applications for any other DEA registrations in California be denied “based on [Respondent's] lack of state authority to practice medicine or handle controlled substances in California.”
I issue this Decision and Order based on the entire record before me. 21 CFR 1301.43(e). I make the following findings of fact.
According to Agency records, Respondent is the holder of DEA Certificate of Registration No. BT1734943 at the registered address of 4982 1/2 Field St. San Diego, CA 92110. Pursuant to this registration, Respondent is authorized to dispense controlled substances in schedules II through V as a practitioner. Respondent's registration expired on November 30, 2021.
On January 31, 2020, the Medical Board of California (hereinafter, the Board) issued an Accusation against Respondent. Government Exhibit (hereinafter, GX) 2, Appendix (hereinafter, App.) A, at 10. The Accusation detailed four causes for discipline against Respondent regarding his treatment of three patients, including repeated negligent acts, failure to maintain adequate and accurate records, unprofessional conduct, and violation of the Medical Practice Act.
On March 18, 2021, the Board issued its Stipulated Surrender of License and Order (hereinafter, Stipulated Surrender).
According to California's online records, of which I take official notice, Respondent's license is still surrendered.
Accordingly, I find that Respondent is not licensed to engage in the practice of medicine in California, the state in which Respondent is registered with the DEA.
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under section 823 of the CSA “upon a finding that the registrant . . . has had his State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, the DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration.
This rule derives from the text of two provisions of the CSA. First, Congress defined the term “practitioner” to mean “a physician . . . or other person licensed, registered, or otherwise permitted, by . . . the jurisdiction in which he practices . . . , to distribute, dispense, . . . [or] administer . . . a controlled substance in the course of professional practice.” 21 U.S.C. 802(21). Second, in setting the requirements for obtaining a practitioner's registration, Congress directed that “[t]he Attorney General shall register practitioners . . . if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.” 21 U.S.C. 823(f). Because Congress has clearly mandated that a practitioner possess state authority in order to be deemed a practitioner under the CSA, the DEA has held repeatedly that revocation of a practitioner's registration is the appropriate sanction whenever he is no longer authorized to dispense controlled substances under the laws of the state in which he practices.
According to California statute, “dispense” means “to deliver a controlled substance to an ultimate user or research subject by or pursuant to the lawful order of a practitioner, including the prescribing, furnishing, packaging, labeling, or compounding necessary to prepare the substance for that delivery.” Cal. Health & Safety Code § 11010 (West, current with urgency legislation through Ch. 770 of 2021 Reg. Sess). Further, a “practitioner” means a person “licensed, registered, or otherwise permitted, to distribute, dispense, conduct research with respect to, or administer, a controlled substance in the course of professional practice or research in this state.”
Here, the undisputed evidence in the record is that Respondent currently lacks authority to practice medicine in California. As already discussed, a physician must be a licensed practitioner to dispense a controlled substance in California. Thus, because Respondent lacks authority to practice medicine in California and, therefore, is not authorized to handle controlled substances in California, Respondent is not eligible to maintain a DEA registration. Accordingly, I will order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a), I hereby revoke DEA Certificate of Registration No. BT1734943 issued to Alex E. Torres. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 823(f), I hereby deny any pending application of Alex E. Torres to renew or modify this registration, as well as any other pending application of Alex E. Torres for additional registration in California. This Order is effective February 22, 2022.
Notice of report.
The report indicates that the Department has not identified any programs that are inconsistent with Buy America requirements of section 70914 of the Act. The report identifies the YouthBuild program as the only Federal financial assistance program related to infrastructure and notes that the grant agreements for that program include the Buy America requirements.
The Acting Chief Financial Officer approved this report on January 14, 2022.
Dylan Sacchetti, 202.693.8105 or at 200 Constitution Ave. NW, Room S-4205, Washington, DC 20210.
The “Build America, Buy America Act,” which was included in the Infrastructure Investment and Jobs Act (the Act) (Pub. L. 117-58), requires under section 70913 that each Federal agency submit a report to the Office of Management and Budget (OMB) and to Congress, and publish it in the
(1) Identify and evaluate all infrastructure programs to determine whether a program is inconsistent with section 70914 of the Act;
(2) identify all domestic content procurement preferences applicable to the Federal financial assistance program related to infrastructure;
(3) assess the applicability of the domestic content procurement preference requirements, including: (A) Section 313 of title 23, United States Code; (B) section 5323(j) of title 49, United States Code; (C) section 22905(a) of title 49, United States Code; (D) section 50101 of title 49, United States Code; (E) section 603 of the Federal Water Pollution Control Act (33 U.S.C. 1388); (F) section 1452(a)(4) of the Safe Drinking Water Act (42 U.S.C. 300j-12(a)(4)); (G) section 5035 of the Water Infrastructure Finance and Innovation Act of 2014 (33 U.S.C. 3 3914); (H) any domestic content procurement preference included in an appropriations Act; and (I) any other domestic content procurement preference in Federal law (including regulations);
(4) provide details on any applicable domestic content procurement preference requirement, including the purpose, scope, applicability, and any exceptions and waivers issued under the requirement; and
(5) include a description of the type of infrastructure projects that receive funding under the program, including information relating to: (A) The number of entities that are participating in the program; (B) the amount of Federal funds that are made available for the program for each fiscal year; and (C) any other information the head of the Federal agency determines to be relevant.
The Department of Labor (the Department) did not receive appropriated funds under the Infrastructure Investment and Jobs Act (the Act).
The Department reviewed its infrastructure programs and has not identified any programs that are inconsistent with section 70914 of the Act.
The Department identified YouthBuild as a Federal financial assistance program related to infrastructure. YouthBuild is a youth training program that provides training and educational services to youth (16-24 years old) using construction and other techniques. This program receives approximately $90 million in annual funding. The Department's Employment and Training Administration awards approximately 65-80 grants each year. A small percentage of the funds is used by recipients to purchase building supplies for building and/or refurbishing houses. Since at least 2014, grant agreements for this program have contained the domestic content procurement preference requirement (
The Department applies the domestic content procurement preference requirement for YouthBuild, by including the following term in all grant agreements:
Pursuant to E.O. 14005, Ensuring the Future Is Made in All of America by All of America's Workers, the grant award recipient agrees to comply with all applicable Made in America Laws (as defined in the E.O.), including the Buy American Act at 41 U.S.C. 8301-8305. For the purposes of this award, the grant recipient is required to maximize the use of goods, products, and materials produced in, and services offered in, the United States, in accordance with the Made in America Laws. No funds may be made available to any person or entity (including as a contractor or subrecipient of the grant recipient) that has been found to be in violation of any Made in America Laws. “Made in America Laws” means all statutes, regulations, rules, and Executive Orders relating to Federal financial assistance awards or Federal procurement, including those that refer to “Buy America” or “Buy American,” that require, or provide a preference for, the purchase or acquisition of goods, products, or materials produced in the United States, including iron, steel, and manufactured goods offered in the United States. Made in America Laws include laws requiring domestic preference for maritime transport, including the Merchant Marine Act of 1920 (Pub. L. 66-261), also known as the Jones Act.
The Department does not have any additional information to provide relating to domestic content procurement preference requirements, including the purpose, scope, applicability and any exceptions and waivers issued under the requirement.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Office of Workers' Compensation Program (OWCP)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before February 22, 2022.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Nora Hernandez by telephone at 202-693-8633 or by email at
Form CA-1032 is used to obtain information from claimants receiving compensation for an extended period of time. This information is necessary to ensure that compensation being paid is correct. For additional substantive information about this ICR, see the related notice published in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Bureau of Labor Statistics, Department of Labor.
Notice of information collection; request for comment.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed extension of the “International Training Application.” A copy of the proposed information collection request can be obtained by contacting the individual listed below in the Addresses section of this notice.
Written comments must be submitted to the office listed in the Addresses section of this notice on or before March 22, 2022.
Send comments to Erin Good, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE, Washington, DC 20212. Written comments also may be transmitted by email to
Erin Good, BLS Clearance Officer, at 202-691-7628 (this is not a toll free number). (See
The BLS is one of the largest labor statistics organizations in the world and has provided international training since 1945. Each year, the BLS Division of International Technical Cooperation (DITC) conducts seminars of 1 to 2 weeks duration at its training facilities in Washington, DC. In addition to the annual international seminars, DITC provides technical assistance upon request and organizes visits to the BLS for many international visitors each year. The seminars bring together statisticians, economists, analysts, and other data producers and users from countries all over the world. Each seminar is designed to strengthen the participants' ability to collect and analyze economic and labor statistics.
Office of Management and Budget clearance is being sought for the proposed extension of the International Training Application. Continuing the existing collection will allow the BLS to continue to conduct international seminars. No questions have been added or deleted on the form since the last Office of Management and Budget approval.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance request for comment to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This request helps to ensure that: Requested data can be provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Explosive Materials and Blasting Units (pertains only to underground metal and Category III nonmetal mines deemed to be gassy).
All comments must be received on or before March 22, 2022.
You may submit comments as follows. Please note that late comments will not be considered.
•
• If your comment includes confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission.
•
• MSHA will post your comment as well as any attachments, except for information submitted and marked as confidential, in the docket at
S. Aromie Noe, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal or other mines.
Under 30 CFR parts 7 and 15, MSHA evaluates and approves explosive materials and blasting units as permissible for use in mines. However, some underground metal and nonmetal Category III mines (gassy mines) use non-approved explosive materials or blasting units because there are no approved explosive materials and blasting units.
MSHA is soliciting comments concerning the proposed information collection related to Explosive Materials and Blasting Units (pertains only to underground metal and Category III nonmetal mines deemed to be gassy). MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden related to the information collection, including the validity of the methodology and assumptions used in the estimate;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the information collection on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Background documents related to this information collection request are
This information collection request concerns provisions for explosive materials and blasting units that pertain only to underground metal and Category III nonmetal mines deemed to be gassy. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request from the previous information collection request.
Comments submitted in response to this notice will be summarized in the request for Office of Management and Budget approval of the proposed information collection request; they will become a matter of public record and will be available at
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance request for comment to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This request helps to ensure that: Requested data can be provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Training Plans, New Miner Training, and Newly-hired Experienced Miner Training.
All comments must be received on or before March 22, 2022.
You may submit comments as follows. Please note that late comments will not be considered.
•
• If your comment includes confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission.
•
• MSHA will post your comment as well as any attachments, except for information submitted and marked as confidential, in the docket at
S. Aromie Noe, Acting Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 103(h) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 813(h), authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. Further, section 101(a) of the Mine Act, 30 U.S.C. 811(a), authorizes the Secretary of Labor to develop, promulgate, and revise as may be appropriate, improved mandatory health or safety standards for the protection of life and prevention of injuries in coal or other mines.
Training informs miners of safety and health hazards inherent in the workplace and enables them to identify and avoid such hazards. Training becomes even more important in light of certain conditions that can exist when production demands increase, such as an influx of new and less experienced miners and mine operators; longer work hours to meet production demands; and increased demand for contractors who may be less familiar with the dangers on mine property.
MSHA's safety and health training requirements ensure that all miners receive the required training, which would result in a decrease in accidents, injuries, and fatalities. The information obtained from mine operators is used by MSHA during inspections to determine compliance with the requirements concerning the training and retraining of miners engaged in shell dredging, or employed at sand, gravel, surface stone, surface clay, colloidal phosphate, and surface limestone mines.
MSHA is soliciting comments concerning the proposed information collection related to Training Plans, New Miner Training, and Newly-hired Experienced Miner Training. MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden related to the information collection, including the validity of the methodology and assumptions used in the estimate;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the information collection on those who are
Background documents related to this information collection request are available at
This information collection request concerns provisions for training plans, new miner training, and newly-hired experienced miner training. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request from the previous information collection request.
Comments submitted in response to this notice will be summarized in the request for Office of Management and Budget approval of the proposed information collection request; they will become a matter of public record and will be available at
Occupational Safety and Health Administration (OSHA), Labor.
Notice.
In this notice, OSHA announces the applications of MET Laboratories, Inc., for expansion of the recognition as a Nationally Recognized Testing Laboratory (NRTL) and presents the agency's preliminary finding to grant the applications.
Submit comments, information, and documents in response to this notice, or requests for an extension of time to make a submission, on or before February 7, 2022.
Submit comments by any of the following methods:
Information regarding this notice is available from the following sources:
The Occupational Safety and Health Administration is providing notice that MET Laboratories, Inc. (MET), is applying for expansion of the current recognition as a NRTL. MET requests the addition of four test standards to the NRTL scope of recognition.
OSHA recognition of a NRTL signifies that the organization meets the requirements specified in 29 CFR 1910.7. Recognition is an acknowledgment that the organization can perform independent safety testing and certification of the specific products covered within the scope of recognition. Each NRTL's scope of recognition includes (1) the type of products the NRTL may test, with each type specified by the applicable test standard; and (2) the recognized site(s) that has/have the technical capability to perform the product-testing and product-certification activities for test standards within the NRTL's scope. Recognition is not a delegation or grant of government authority; however, recognition enables employers to use products approved by the NRTL to meet OSHA standards that require product testing and certification.
The agency processes applications by a NRTL for initial recognition and for an expansion or renewal of this recognition, following requirements in Appendix A to 29 CFR 1910.7. This appendix requires that the agency publish two notices in the
MET currently has one facility (site) recognized by OSHA for product testing and certification, with its headquarters located at: MET Laboratories, Inc., 914 West Patapsco Avenue, Baltimore, Maryland 21230. A complete list of MET's scope of recognition is available at
MET submitted four applications, one dated January 14, 2019 (OSHA-2006-0028-0075), the second, dated July 30, 2019 (OSHA-2006-0028-0076), which was amended on July 29, 2020 (OSHA-2006-0028-0079). The third and fourth applications were received on August 13, 2019 (OSHA-2006-0028-0077) and (OSHA-2006-0028-0078). Together, the expansion applications would add four additional test standards to MET's NRTL recognition. OSHA staff performed a detailed analysis of the application packets and reviewed other pertinent information. OSHA did not perform any on-site reviews in relation to these applications.
Table 1 below, lists the appropriate test standards found in MET's applications for expansion for testing and certification of products under the NRTL Program.
In reviewing the expansion applications, OSHA discovered that the standard TIA 4950 had been revised in May 2014 (Revision A) and July 2020 (Revision B). OSHA examined these revisions and preliminarily determined that they are not substantive in nature. Therefore, OSHA has preliminarily determined that the current version of TIA 4950 (Revision B) remains an appropriate test standard under the NRTL Program Regulation, 29 CFR 1910.7, and that OSHA need not reevaluate the recognition of any NRTLs currently recognized for TIA 4950. Moreover, although MET's expansion application sought recognition for TIA 4950A only, and not TIA 4950B (see OSHA-2006-0028-0076; OSHA-2006-0028-0079), OSHA preliminarily concludes that MET's application for expansion, if granted, will include recognition for the current version of TIA 4950 (again, because any changes made in Revision B are not substantive). OSHA welcomes comment on these determinations.
MET submitted acceptable applications for expansion of the scope of recognition. OSHA's review of the application files, and pertinent documentation, indicate that MET can meet the requirements prescribed by 29 CFR 1910.7 for expanding the recognition to include the addition of these four test standards for NRTL testing and certification listed in Table 2. This preliminary finding does not constitute an interim or temporary approval of MET's applications.
OSHA welcomes public comment as to whether MET meets the requirements of 29 CFR 1910.7 for expansion of the recognition as a NRTL. Comments should consist of pertinent written documents and exhibits. Commenters needing more time to comment must submit a request in writing, stating the reasons for the request. Commenters must submit the written request for an extension by the due date for comments. OSHA will limit any extension to 10 days unless the requester justifies a longer period. OSHA may deny a request for an extension if the request is not adequately justified. To obtain or review copies of the exhibits identified in this notice, as well as comments submitted to the docket, contact the Docket Office, at the above address. These materials also are available online at
OSHA staff will review all comments to the docket submitted in a timely manner and, after addressing the issues raised by these comments, will make a recommendation to the Assistant Secretary for Occupational Safety and Health whether to grant MET's applications for expansion of the scope of recognition. The Assistant Secretary will make the final decision on granting the applications. In making this decision, the Assistant Secretary may undertake other proceedings prescribed in Appendix A to 29 CFR 1910.7.
OSHA will publish a public notice of the final decision in the
Douglas L. Parker, Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice. Accordingly, the agency is issuing this notice pursuant to Section 29 U.S.C. 657(g)(2), Secretary of Labor's Order No. 8-2020 (85 FR 58393; Sept. 18, 2020), and 29 CFR 1910.7.
Occupational Safety and Health Administration (OSHA), Labor.
Request for Nominations for Employee Representative on the Advisory Committee on Construction Safety and Health (ACCSH).
The Secretary of Labor requests nominations for an employee representative on ACCSH.
Submit (postmark, send, transmit) nominations for ACCSH membership by February 22, 2022.
You may submit nominations and supporting materials by the following method:
The Secretary of Labor invites interested persons to submit nominations to fill one membership position for an Employee Representative on the Advisory Committee on Construction Safety and Health (ACCSH).
ACCSH advises the Secretary of Labor and the Assistant Secretary of Labor for Occupational Safety and Health (Assistant Secretary) in the formulation of standards affecting the construction industry, and on policy matters arising in the administration of the safety and health provisions under the Contract Work Hours and Safety Standards Act (Construction Safety Act (CSA)) (40 U.S.C. 3701
ACCSH operates in accordance with the Federal Advisory Committee Act (FACA), as amended (5 U.S.C. App. 2), and the implementing regulations (41 CFR 102-3
ACCSH consists of 15 members whom the Secretary appoints. ACCSH members generally serve staggered two-year terms, unless they resign, cease to be qualified, become unable to serve, or the Secretary removes them (29 CFR 1912.3(e)). The Secretary may appoint ACCSH members to successive terms. No member of ACCSH, other than members who represent employers or employees, shall have an economic interest in any proposed rule that affects the construction industry (29 CFR 1912.6).
The categories of ACCSH membership are:
• Five members who are qualified by experience and affiliation to present the viewpoint of employers in the construction industry;
• Five members who are similarly qualified to present the viewpoint of employees in the construction industry;
• Two representatives of State safety and health agencies;
• Two public members, qualified by knowledge and experience to make a useful contribution to the work of ACCSH, such as those who have professional or technical experience and competence with occupational safety and health in the construction industry; and
• One representative designated by the Secretary of the Department of Health and Human Services and appointed by the Secretary.
With this notice, OSHA is seeking to fill one vacant Employee Representative position. The Department of Labor is committed to equal opportunity in the workplace and seeks broad-based and diverse ACCSH membership. Any interested person or organization may self-nominate or nominate one or more other individuals for membership on ACCSH. Interested persons also are invited and encouraged to submit statements in support of nominees.
Nominations must include the following information:
• Nominee's contact information and current employment or position;
• Nominee's résumé or curriculum vitae, including prior membership on ACCSH and other relevant organizations and associations;
• A summary of the background, experience, and qualifications that addresses the nominee's suitability for nomination as an Employee Representative;
• Articles or other documents the nominee has authored that indicate the nominee's knowledge, experience, and expertise in occupational safety and health, particularly as it pertains to the construction industry; and
• A statement that the nominee is aware of the nomination, is willing to regularly attend and participate in ACCSH meetings, and has no conflicts of interest that would preclude membership on ACCSH.
The Secretary will select the ACCSH member on the basis of their experience, knowledge, and competence in the field of occupational safety and health, particularly as it pertains to the construction industry. Information received through this nomination process, in addition to other relevant sources of information, will assist the Secretary in making this appointment to ACCSH. The Secretary will consider individuals nominated in response to this
Douglas L. Parker, Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice under the authority granted by 29 U.S.C. 655(b)(1) and 656(b), 40 U.S.C. 3704(a)(2), 5 U.S.C. App. 2, Secretary of Labor's Order No. 8-2020 (85 FR 58393), and 29 CFR part 1912.
Millennium Challenge Corporation.
Notice.
In accordance with the Millennium Challenge Act of 2003, as amended, the Millennium Challenge Corporation is publishing a summary, justification, and full text of the proposed First Amendment to Millennium Challenge Compact between the United States of America, acting through the Millennium Challenge Corporation, and the Republic of Niger, acting through the Ministry in Charge of Foreign Affairs and Cooperation. Representatives of the United States Government and the Government of Niger plan to conclude the Amendment in January 2022.
The Board of Directors of the Millennium Challenge Corporation (“
The Compact was signed July 29, 2016 and entered into force on January 26, 2018. The Compact aims to increase rural incomes through improvements in agricultural productivity and sales resulting from modernized irrigated agriculture with sufficient trade and market access; and to increase incomes for small-scale agriculture-dependent and livestock-dependent families in eligible municipalities in rural Niger by improving crop and livestock productivity, sustaining natural resources critical to long-term productivity, and increasing market sales of targeted commodities through two projects: The Irrigation and Market Access Project and Climate-Resilient Communities Project.
MCC proposes to extend the term of the Compact for an additional 12 months to January 26, 2024 and to provide additional funding up to $5,600,000. The term extension is necessary to mitigate implementation delays due to the COVID-19 pandemic and to complete projects as originally contemplated. The proposed additional funding will be used to cover additional program administration and related oversight costs associated with extending the Compact's term.
Niger registered its first COVID-19 case on March 19, 2020. Within weeks, the Government of Niger imposed a tight lock-down closing international airports and land borders, restricting movements between cities, shuttering hotels, limiting gatherings to ten people or less, and enforcing a nightly curfew. Over the course of the next two months, the U.S. Embassy evacuated over 400 Americans and placed MCC staff who remained in country on mandatory telework status. Restrictions on movement and gatherings were eased in May 2020. International air travel reassumed with strict sanitary protocols that included 14-day quarantines upon arrival in Niger. International airlines, however, did not resume flights into Niger until August and September 2020.
Since the outbreak began in March 2020, COVID-19 has significantly delayed Compact implementation. Several Millennium Challenge Account-Niger (“
Extending the Compact term will enable MCC and the Government of Niger to complete and hand over all ongoing projects to the beneficiary institutions at the required quality, without compromising health, safety, and environmental standards, and will reduce sustainability risks through finalization of farmer training and land tenure support activities and testing of the new innovative road maintenance arrangement. The Compact extension will also maximize long-term results and benefits for the citizens of Niger, and MCC's return on investment, and benefit the Compact program as a whole. The additional funding will be used to cover additional program administration and related oversight costs associated with extending the Compact's term.
This FIRST AMENDMENT TO MILLENNIUM CHALLENGE COMPACT (this “
Section 1.3 (Project Objectives) of the Compact is amended and restated to read as follows:
“Section 1.3
(a) increase rural incomes through improvements in agricultural productivity and increases in sales resulting from modernized irrigated agriculture with sufficient trade and market access; and
(b) increase incomes for small-scale agricultural- and livestock-dependent families in Eligible Communes and Livestock Corridors in rural Niger by improving crop and livestock productivity, sustaining natural resources critical to production, supporting growth of agricultural enterprises and increasing market sales of targeted commodities.”
Section 2.1 (Program Funding) of the Compact is amended and restated to read as follows:
“Section 2.1
Section 7.4 (Compact Term) of the Compact is amended and restated to read as follows:
“Section 7.4
(a) Exhibit A to Annex II (Multi-Year Financial Plan Summary) to the Compact is deleted in its entirety and replaced by revised Exhibit A set forth in Annex I to this Amendment, which revised Exhibit A includes the Compact Development Funding amount granted by implementation of Section 2.2(d) of the Compact.
Each Party hereby covenants and agrees, without necessity of any further consideration, to execute and deliver any and all such further documents and take any and all such other action as may be reasonably necessary or appropriate to carry out the intent and purpose of this Amendment.
From and after the date this Amendment enters into force, the Compact and this Amendment will be read together and construed as one document, and each reference in the Compact to the “Compact,” “hereunder,” “hereof” or words of like import referring to the Compact, and each reference to the “Compact,” “thereunder,” “thereof” or words of like import in any Supplemental Agreement or in any other document or instrument delivered pursuant to the Compact or any Supplemental Agreement, will mean and be construed as a reference to the Compact, as amended by this Amendment.
Except as expressly amended by this Amendment, all of the provisions of the Compact remain unchanged and in full force and effect.
The Parties acknowledge and agree that this Amendment is an international agreement entered into for the purpose of amending the Compact and as such will be interpreted in a manner consistent with the Compact and is governed by international law.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Advisory Committee. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Tuesday, February 15, 2022, 12:00 p.m. to 6:00 p.m., Eastern Time.
Meeting will be virtual only. See dial-in information below under
Ms. Karshelia Kinard, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2355 or
As noted above, this meeting will be available to the public by WebEx only. The meeting event address for attendees is:
The agenda for the meeting includes the following topics:
It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of the key participants.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Ohio State 2nd Year Virtual Site Visit (1203).
May 5, 2022; 9:30 a.m.—4:00 p.m.
NSF 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Cosima Boswell-Koller, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; 703-292-8800.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Minnesota 2nd Year Virtual Site Visit (1203).
May 19, 2022, 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Cosima Boswell-Koller, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; 703/292-8800.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Chicago 2nd Year Virtual Site Visit (1203).
May 16, 2022, 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Miriam Deutsch, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; Telephone: (703) 292-5360.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
National Science Foundation.
Notice.
The Division of Acquisition and Cooperative Support within the National Science Foundation (NSF) is publishing this notice to advise the public of the report that reflects the National Science Foundation's analysis of financial assistance-funded infrastructure programs and associated Build America, Buy America requirements. NSF has focused on infrastructure related to science and education programs.
Patrick Breen, Division Director, Division of Acquisition and Cooperative Support, National Science Foundation. Phone: 703-292-7719; email:
After OMB releases implementation guidance subject to section 70915 of the Infrastructure Investment and Jobs Act, the National Science Foundation will work closely with OMB to ensure that appropriate agency programs that are subject to Build America, Buy America requirements are administered with those requirements in place and will adhere to forthcoming OMB guidance. This analysis is subject to change upon further evaluation.
In accordance with Section 70913 of the Infrastructure Investment and Jobs Act (IIJA), which includes the “Build America, Buy America Act” (the Act), the National Science Foundation (NSF) is submitting the following information to the Office of Management and Budget (OMB) and Congress. Additionally, NSF will publish this report in the
On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act, which includes the “Build America, Buy America Act”. This Act requires agencies submit to the OMB and Congress a report within 60 days of its enactment, January 14, 2022, listing all Federal financial assistance programs for infrastructure administered by the agency. As required by the Act, this report will also be published in the
In accordance with the Act, NSF's 60-day report includes the following information:
1. Identification of all domestic content procurement preferences applicable to Federal financial assistance;
2. An assessment of the application of the domestic content procurement preference requirements;
3. Details on any applicable domestic content procurement preference requirement, including the purpose, scope, applicability, and any exceptions and waivers issued under the requirement;
4. A description of the type of infrastructure projects that receive funding under the program; and
5. Identification and evaluation of all infrastructure programs to determine if they are inconsistent with section 70914 of the Act.
NSF has implemented one article in its Grant General Conditions (GC-1).
Article 44, Domestic Preference for Procurements, notifies awardees of the applicability of 2 CFR 200.322, entitled Domestic Preferences for Procurements. The Article, and the reference to 2 CFR 200.322, ensure that recipients provide preference for the purchase, acquisition, or use of goods, products, or materials produced in the United States. These items include, but are not limited to, iron, aluminum, steel, cement, and other manufactured products.
NSF has implemented two articles in its Cooperative Agreement Financial and Administrative Terms and Conditions (CA-FATC).
Article 45, Domestic Preference for Procurements, notifies awardees of the applicability of 2 CFR 200.322, entitled Domestic Preferences for Procurements. The Article, and the reference to 2 CFR 200.322, ensure that recipients provide preference for the purchase, acquisition, or use of goods, products, or materials produced in the United States. These items include, but are not limited to, iron, aluminum, steel, cement, and other manufactured products.
Article 46, Made in America, applies to major facility construction stage awards and mid-scale research infrastructure implementation awards greater than $20 million and notifies these awardees that they must retain appropriate documentation to substantiate any circumstance where the awardee has deemed a U.S. preference is not feasible in acquiring goods,
NSF reviewed the authorities listed in section 70913(b)(2)(A)-(G) of the Act. The listed authorities are not appliable to financial assistance awards issued by NSF. There are no NSF-specific statutes which require a domestic preference in NSF financial assistance programs.
In reviewing other authorities, and as stated above, 2 CFR 200.322, Domestic Preference for Procurements, is included in the financial assistance awards issued by NSF subject to GC-1, or the CA-FATC.
As stated above, as of November 12, 2020, 2 CFR 200.322, Domestic Preferences for Procurements, from the Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards applies to NSF financial assistance awards. NSF further reemphasized this new requirement by adding new terms and conditions to grants and cooperative agreements issued by NSF on or after October 4, 2021. Article 44 of the GC-1 and Article 45 of the CA-FATC are included in awards to ensure recipients are aware of the preference for the purchase, acquisition, or use of goods, products, or materials produced in the United States. Further, the reference to 2 CFR 200.322 ensures the use of common definitions of “produced in the United States” and “manufactured products”.
The text of Article 44 of the GC-1 and Article 45 of the CA-FATC, Domestic Preferences for Procurements is:
The awardee is notified of the applicability of 2 CFR 200.322, entitled Domestic Preferences for Procurements.
Article 46 of the CA-FATC, which applies to major facility construction stage awards and mid-Scale research infrastructure implementation awards greater than $20 million, adds an additional requirement. See definitions in Section 4 below. This article requires the recipient to document and substantiate any circumstance where the recipient has deemed a U.S. preference not feasible in acquiring goods, products, or materials which could then be reviewed by NSF upon request.
The text of Article 46, Made in America is:
In implementation of 2 CFR 200.322, major facility construction stage awards and mid-Scale research infrastructure implementation awards greater than $20 million must retain appropriate documentation to substantiate any circumstance where the awardee has deemed a U.S. preference not feasible in acquiring goods, products, or materials. The documentation must identify the basis for the determination and be based on:
a. Domestic non-availability—articles, materials, or supplies are not mined, produced, or manufactured in sufficient and reasonably available commercial quantities and of a satisfactory quality to meet technical or operational requirements;
b. Unreasonable cost—the price of the domestic end product (including transport to the construction site) is higher than the price of a foreign end product by 30 percent if offered by small business or 20 percent if offered by other than a small business;
c. The purchase is related to commercially-available information technology; and/or
d. The purchases are at or below the micro-purchase threshold (currently $10,000 for most acquisitions) or related to procurements for use outside of the United States.
The requirements of this article must be included in all subawards, contracts and purchase orders for work or products under this award.
NSF is not aware of any exercise of exceptions or waivers requested as to the domestic preference requirements established by 2 CFR 200.322 as implemented through GC-1 or the CA-FATC.
As an integral part of its responsibility for strengthening the science and engineering capacity of the country, NSF provides support for the design, construction, operation, and upgrade of research infrastructure. NSF defines research infrastructure as any combination of facilities, equipment, instrumentation, computational hardware and software, and the necessary supporting human capital. Research infrastructure includes major research instrumentation, mid-scale projects, and major facilities.
NSF typically supports research infrastructure construction from two appropriations accounts: The Major Research Equipment and Facility Construction (MREFC) account and the Research and Related Activities (R&RA) account, but additional support may come from the Education and Human Resources (EHR) Account.
The MREFC account was created in 1995 to fund the acquisition, construction, commissioning, and upgrading of major science and engineering infrastructure projects that could not be otherwise supported by NSF directorate-level budgets without a severe negative impact on funded science. MREFC projects generally range in cost from one hundred million to several hundred million dollars expended over a multi-year period.
The R&RA account is used to support other activities involving a major facility that the MREFC account cannot support, including planning and development, design, operations and maintenance, and associated scientific research. Construction and acquisition projects at a smaller scale, usually of a scale ranging from millions to tens of millions of dollars, are also normally supported from the R&RA account unless a specific program is included in the MREFC account.
Per Section 110 of the 2017 American Innovation and Competitiveness Act (AICA), as amended, a major multi-use research facility project (major facility) is defined as follows:
“(2) MAJOR MULTI-USER RESEARCH FACILITY PROJECT. The term `major multi-user research facility project' means a science and engineering facility project that exceeds $100,000,000 in total construction, acquisition, or upgrade costs to the Foundation.” (42 U.S.C. 1862s-2(g)(2)).
NSF interprets the above to mean the Total Project Costs (TPC) as defined by the investment in construction or acquisition, not the operations or associated science program costs. If the TPC for research infrastructure is above the major facility project threshold as defined by statute, it is considered a major facility throughout its full life cycle.
Per Section 109 of AICA, a mid-scale project means research instrumentation, equipment, and upgrades to major research facilities or other research infrastructure investments that exceeds the maximum funded by the Major Research Instrumentation (MRI) program (currently $4M) and are below that of a major facility. Similar to major facilities, mid-scale projects may also involve development and design, construction or acquisition, operations, and eventual divestment.
For the purposes of implementing the Act and reporting the figures below, NSF defines “infrastructure” as any mid-scale project over $20M and all major facilities, including upgrades to major facilities. At this time design, operations and routine maintenance
Currently NSF is fully compliant with all domestic preference requirements effective on the date of this report that are applicable to the Federal financial assistance awards issued by NSF.
Section 70914(a) of the Act requires the following:
“Not later than 180 days after the date of enactment of this Act, the head of each Federal agency shall ensure that none of the funds made available for a Federal financial assistance program for infrastructure, including each deficient program, may be obligated for a project unless all of the iron, steel, manufactured products, and construction materials used in the project are produced in the United States.”
NSF will update its terms and conditions for affected programs to comply with this section of the Act on or before May 14, 2022.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Brandeis 2nd Year Virtual Site Visit (1203).
April 26, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Miriam Deutsch, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; Telephone: (703) 292-5360.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Princeton 2nd Year Virtual Site Visit (1203).
April 21, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Cosima Boswell-Koller, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; 703-292-8800.
Site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Minnesota 2nd Year Virtual Site Visit (1203).
April 15, 2022, 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Miriam Deutsch, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; Telephone: (703) 292-5360.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—UCSD 2nd Year Virtual Site Visit (1203).
April 27, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Miriam Deutsch, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; Telephone: (703) 292-5360.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Irvine 2nd Year Virtual Site Visit (1203).
May 25, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Cosima Boswell-Koller, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; 703/292-8800.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Columbia 2nd Year Virtual Site Visit (1203).
April 28, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Cosima Boswell-Koller, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; 703-292-8800.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Delaware 2nd Year Virtual Site Visit (1203).
May 23, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Miriam Deutsch, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; Telephone: (703) 292-5360.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
MRSEC—Penn State 2nd Year Virtual Site Visit (1203).
May 2, 2022; 9:30 a.m.-4:00 p.m.
NSF, 2415 Eisenhower Avenue, Alexandria, VA 22314 | Virtual.
Part-Open.
Dr. Miriam Deutsch, Program Director, Division of Materials Research, National Science Foundation, 2415 Eisenhower Avenue, Room W 9216, Alexandria, VA 22314; Telephone: (703) 292-5360.
Virtual site visit to provide an evaluation of the progress of the projects at the host site for the Division of Materials Research at the National Science Foundation.
The work being reviewed during closed portions of the virtual site visit include information of a proprietary or confidential nature, including technical information; financial data, such as salaries and personal information concerning individuals associated with the project. These matters are exempt under 5 U.S.C. 552b(c), (4) and (6) of the Government in the Sunshine Act.
The National Science Board's Executive Committee hereby gives notice of the scheduling of a teleconference for the transaction of National Science Board business, pursuant to the National Science Foundation Act and the Government in the Sunshine Act.
Wednesday, January 26, 2022, from 4:00-5:00 p.m. EST.
This meeting will be held by teleconference through the National Science Foundation.
Open.
Committee Chair's opening remarks; approval of Executive Committee minutes of November 8, 2021; and discuss issues and topics for an agenda of the NSB
Point of contact for this meeting is: Nirmala Kannankutty, 703/292-8000. To listen to this teleconference, members of the public must send an email to
Weeks of January 24, 31, February 7, 14, 21, 28, 2022.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public.
There are no meetings scheduled for the week of January 31, 2022.
There are no meetings scheduled for the week of February 14, 2022.
There are no meetings scheduled for the week of February 28, 2022.
For more information or to verify the status of meetings, contact Wesley Held at 301-287-3591 or via email at
The NRC Commission Meeting Schedule can be found on the internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555, at 301-415-1969, or by email at
The NRC is holding the meetings under the authority of the Government in the Sunshine Act, 5 U.S.C. 552b.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Application for indirect transfer of licenses; opportunity to comment, request a hearing, and petition for leave to intervene.
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of a license transfer application filed by Energy
Submit Comments by February 22, 2022. A request for a hearing must be filed by February 10, 2022. Any potential party as defined in § 2.4 of title 10 of the
Please refer to Docket ID NRC-2021-0232 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Jack D. Parrott, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-6634, email:
Please refer to Docket ID NRC-2021-0232 when contacting the NRC about the availability of information for this action. You may obtain publicly available information related to this action by any of the following methods:
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The NRC encourages electronic comment submission through the Federal Rulemaking website (
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS.
The NRC is considering the issuance of an order under 10 CFR 30.34(b), 50.80, 72.50, and 110.50(d) approving the indirect transfer of control of Facility Operating License Nos. DPR-39 and DPR-48 for Zion, Units 1 and 2, respectively, and the general license for the Zion ISFSI; Possession Only License No. DPR-73 for TMI-2; Possession Only License No. DPR-45 for La Crosse and the general license for the La Crosse ISFSI; Radioactive Materials License No. 39-35044-01; and Export Licenses XW010/04 and XW018/01 from the current principal shareholders of the Energy
According to the application for approval filed by, Energy
The NRC's regulations at 10 CFR 30.34(b), 50.80, and 72.50 state that no license, or any right thereunder, shall be transferred, directly or indirectly, through transfer of control of the license, unless the Commission gives its consent in writing. The NRC's regulations at 10 CFR 110.50(d) state that a specific export license may be transferred only with the approval of the Commission. The Commission will approve an application for the indirect transfer of a license, if the Commission determines that the proposed transfer will not affect the qualifications of the licensee to hold the license, and that the transfer is otherwise consistent with applicable provisions of law, regulations, and orders issued by the Commission.
Within 30 days from the date of publication of this notice, persons may submit written comments regarding the license transfer application, as provided for in 10 CFR 2.1305. The Commission will consider and, if appropriate, respond to these comments, but such comments will not otherwise constitute part of the decisional record. Comments should be submitted as described in the
Within 20 days after the date of publication of this notice, any person (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's website at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 20 days from the date of publication of this notice in accordance with the filing instructions in the “Electronic Submissions (E-Filing”) section of this document. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii).
A State, local governmental body, Federally recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission no later than 20 days from the date of publication of this notice. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section. Alternatively, a State, local governmental body, Federally recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings including documents filed by an interested State, local governmental body, Federally recognized Indian Tribe, or agency thereof that requests to participate under 10 CFR 2.315(c), must be filed in accordance with 10 CFR 2.302. The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases, to mail copies on electronic storage media, unless an exemption permitting an alternative filing method, as discussed below, is granted. Detailed guidance on electronic submissions is located in the Guidance for Electronic Submissions to the NRC (ADAMS Accession No. ML13031A056) and on the NRC website at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of
Information about applying for a digital ID certificate is available on the NRC's public website at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public website at
Participants who believe that they have good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted in accordance with 10 CFR 2.302(b)-(d). Participants filing adjudicatory documents in this manner are responsible for serving their documents on all other participants. Participants granted an exemption under 10 CFR 2.302(g)(2) must still meet the electronic formatting requirement in 10 CFR 2.302(g)(1), unless the participant also seeks and is granted an exemption from 10 CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket, which is publicly available at
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
For further details with respect to this application, see the application dated December 7, 2021 (ADAMS Package Accession No. ML21344A114).
Any person who desires access to proprietary, confidential commercial information that has been redacted from the application should contact the applicant by telephoning Gerard P. Van Noordennen, Senior Vice President Regulatory Affairs, Energy
For the Nuclear Regulatory Commission.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold an Open Meeting on Wednesday, January 26, 2022 at 10:00 a.m.
The meeting will be webcast on the Commission's website at
The meeting will begin at 10:00 a.m. (ET) and will be open to the public via webcast on the Commission's website at
1. The Commission will consider whether to propose amendments to Form PF to require current reporting and amend reporting requirements.
2. The Commission will consider whether to propose amendments to the definition of an exchange under the Securities Exchange Act of 1934 and re-propose amendments to Regulation ATS for ATSs That Trade U.S. Government Securities, NMS Stock, and Other Securities and to Regulation SCI for ATSs That Trade U.S. Government Securities.
For further information and to ascertain
Notice.
A determination has been made pursuant to the Arms Export Control Act and Export Administration Act.
Consistent with section 654(c) of the Foreign Assistance Act of 1961, as amended, notice is hereby given that the Secretary of State has made a determination pursuant to Section 73 of the Arms Export Control Act (22 U.S.C. 2797b) and Section 11B(b) of the Export Administration Act of 1979 (50 U.S.C. 4612). [Note: Although the Export Administration Act of 1979 lapsed in 2001 and was partially repealed in 2018, authorities under Section 11B continue to be carried out under the International Emergency Economic Powers Act, 50 U.S.C. 1701-1708, pursuant to the emergency declared in E.O. 13222 of August 17, 2001, which has been kept in effect by successive Presidential Notices, the most recent of which was the Notice of August 6, 2021, 86 FR 43901, (Aug. 10, 2021).] The Secretary of State has concluded that publication of the determination would be harmful to the national security of the United States.
Notice.
A determination has been made that PRC entities have engaged in activities that require the imposition of measures pursuant to the Arms Export Control Act, as amended, and the Export Administration Act of 1979, as amended.
Pam Durham, Office of Missile, Biological, and Chemical Nonproliferation, Bureau of International Security and Nonproliferation, Department of State (202-647-4930). On import ban issues, Lauren Sun, Assistant Director for Regulatory Affairs, Department of the Treasury (202-622-4855). On U.S. Government procurement ban issues, Eric Moore, Office of the Procurement Executive, Department of State (703-875-4079).
Pursuant to Section 73(a)(1) of the Arms Export Control Act [22 U.S.C. 2797b(a)(1)]; Section 11B(b)(1) of the Export Administration Act of 1979 [ (50 U.S.C. 4612)], as carried out under E.O. 13222 of August 17, 2001 (hereinafter cited as the “Export Administration Act of 1979”); [Note: Although the Export Administration Act of 1979 lapsed in 2001 and was partially repealed in 2018, authorities under Section 11B continue to be carried out under the International Emergency Economic Powers Act, 50 U.S.C. 1701-1708, pursuant to the emergency declared in E.O. 13222 of August 17, 2001, which has been kept in effect by successive Presidential Notices, the most recent of which was the Notice of August 6, 2021, 86 FR 43901, (Aug. 10, 2021). End Note], the U.S. Government has determined that the following foreign persons have engaged in missile technology proliferation activities that require the imposition of the sanctions described in Sections 73(a)(2)(B) and (C) of the Arms Export Control Act [22 U.S.C. 2797b(a)(2)(B) and (C)] and Sections 11B(b)(1)(B)(ii) and (iii) of the Export Administration Act of 1979 [50 U.S.C. app. 2410b(b)(1)(B)(ii) and (iii)] on these entities:
China Aerospace Science and Technology Corporation (CASC) First Academy, and its sub-units and successors;
China Aerospace Science and Industry Corporation (CASIC) Fourth Academy, and its sub-units and successors; and
Poly Technologies Incorporated (PTI), and its sub-units and successors.
Accordingly, the following sanctions are being imposed on these entities for two years:
(A) Denial of all new individual licenses for the transfer to the sanctioned entities of all items on the U.S. Munitions List and all items the export of which is controlled under the Export Control Reform Act (ECRA) of 2018;
(B) Denial of all U.S. Government contracts with the sanctioned entities; and
(C) Prohibition on the importation into the United States of all products produced by the sanctioned entities.
With respect to items controlled pursuant to the ECRA of 2018, the above export sanction only applies to exports made pursuant to individual export licenses.
These measures shall be implemented by the responsible departments and agencies of the United States Government as provided in E.O. 12851 of June 11, 1993.
Verdigris Southern Railroad, L.L.C. (VESO), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to lease from the City of Tulsa-Rogers County Port Authority (the Port), and to commence common carrier operations over, certain track owned by the Port (also a noncarrier) located in Rogers County, Okla. (the Line). The Line extends from the point of connection to the northwest-southeast-running Union Pacific Railroad Company (UP) Wagoner Subdivision mainline at UP milepost 594.76 at Inola, Okla., westward for a distance of approximately 13,883 feet to an end point to the west of the Line's at-grade crossing of State Road S 4200. According to VESO, the Line currently serves as a private track and has no mileposts of its own.
This transaction is related to a verified notice of exemption filed concurrently in
The verified notice states that VESO and the Port have entered into a Track
VESO certifies that its projected annual revenues from this transaction will not result in its becoming a Class I or Class II rail carrier and will not exceed $5 million. VESO also certifies that the Agreement does not include an interchange commitment.
The earliest this transaction may be consummated is February 6, 2022, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than January 28, 2022 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36571, should be filed with the Surface Transportation Board via e-filing on the Board's website. In addition, a copy of each pleading must be served on VESO's representative, Bradon J. Smith, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 800, Chicago, IL 60606.
According to VESO, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic preservation reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Watco Holdings, Inc. (Watco), a noncarrier, has filed a verified notice of exemption under 49 CFR 1180.2(d)(2) to continue in control of Verdigris Southern Railroad, L.L.C. (VESO), a noncarrier controlled by Watco, upon VESO's becoming a Class III rail carrier.
This transaction is related to a verified notice of exemption filed concurrently in
The transaction may be consummated on or after February 6, 2022, the effective date of the exemption (30 days after the verified notice was filed).
According to the verified notice of exemption, Watco currently controls indirectly 40 Class III railroads and one Class II railroad, collectively operating in 28 states. For a complete list of these rail carriers and the states in which they operate, see the Appendix to Watco's January 7, 2022 verified notice of exemption, available at
Watco represents that: (1) The rail line to be operated by VESO does not connect with the rail lines of any of the rail carriers currently controlled by Watco; (2) this transaction is not part of a series of anticipated transactions that would connect VESO with any railroad in the Watco corporate family; and (3) the transaction does not involve a Class I rail carrier. The proposed transaction is therefore exempt from the prior approval requirements of 49 U.S.C. 11323 pursuant to 49 CFR 1180.2(d)(2). Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Because the transaction involves the control of one Class II and one or more Class III rail carriers, the transaction is subject to the labor protection requirements of 49 U.S.C. 11326(b) and
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than January 28, 2022 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36572, should be filed with the Surface Transportation Board via e-filing on the Board's website. In addition, one copy of each pleading must be served on Watco's representative, Bradon J. Smith, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 800, Chicago, IL 60606.
According to Watco, this action is categorically excluded from environmental review under 49 CFR 1105.6(c) and from historic reporting requirements under 49 CFR 1105.8(b).
Board decisions and notices are available at
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Aviation Administration (FAA), DOT.
Notice of request to rule on release of airport property for land disposal at the Ottumwa Regional Airport (OTM), Ottumwa, Iowa.
The FAA proposes to rule and invites public comment on the release of land at the Ottumwa Regional Airport (OTM), Ottumwa, Iowa.
Comments must be received on or before February 22, 2022.
Comments on this application may be mailed or delivered to the FAA at the following address: Amy J. Walter, Airports Land Specialist, Federal Aviation Administration, Airports Division, ACE-620G, 901 Locust, Room 364, Kansas City, MO 64106.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to: Zach Simonson, Community Development Director, City of Ottumwa, 105 East Third Street, Ottumwa, Iowa 52501, (641) 683-0694.
Amy J. Walter, Airports Land Specialist, Federal Aviation Administration, Airports Division, ACE-620G, 901 Locust, Room 364, Kansas City, MO 64106, (816) 329-2603,
The FAA invites public comment on the request to release two tracts of land: Parcel 64 is 4.51 acres and parcel 67 is 2.06 acres
The following is a brief overview of the request:
The Ottumwa Regional Airport (OTM) is proposing the release of two airport parcels containing 4.51 acres and 2.06 acres. The release of land is necessary to comply with Federal Aviation Administration Grant Assurances that do not allow federally acquired airport property to be used for non-aviation purposes. The sale of the subject property will result in the land at the Ottumwa Regional Airport (OTM) being changed from aeronautical to non-aeronautical use and release the lands from the conditions of the Airport Improvement Program Grant Agreement Grant Assurances in order to dispose of the land. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will receive fair market value for the property, which will be subsequently reinvested in another eligible airport improvement project for general aviation use.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
Hankook Tire America Corporation (Hankook) has determined that certain Hankook Dynapro MT2 tires, do not fully comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 139,
Jayton Lindley, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), (325) 655-0547,
Hankook has determined that certain Hankook Dynapro MT2 tires, do not fully comply with paragraph S5.5(f) of FMVSS No. 139,
Hankook filed a noncompliance report dated February 19, 2020, pursuant to 49 CFR part 573,
Notice of receipt of Hankook's petition was published with a 30-day public comment period, on August 28, 2020, in the
Approximately 175 Hankook Dynapro MT2 tires, size LT215/85R16, manufactured between October 20, 2019, and November 30, 2019, are potentially involved.
Hankook explains that the noncompliance is that the subject tires were marked with the incorrect number of nylon plies in the tread; and, therefore, do not meet the requirements of paragraph S5.5(f) of FMVSS No. 139. Specifically, the tires were marked “TREAD 2 STEEL + 2 POLYESTER + 1 NYLON; SIDEWALL 2 POLYESTER”, when they should have been marked “TREAD 2 STEEL + 2 POLYESTER + 2 NYLON; SIDEWALL 2 POLYESTER.”
Paragraph S5.5(f) of FMVSS No. 139, includes the requirements relevant to this petition. Each tire must be marked on one sidewall with the actual number of plies in the sidewall and the actual number of plies in the tread area, if different, as specified in paragraph S5.5(f).
The following views and arguments presented in this section, “V. Summary of Hankook's Petition,” are the views and arguments provided by Hankook and do not reflect the views of the Agency. In its petition, Hankook describes the subject noncompliance and contends that the noncompliance is inconsequential as it relates to motor vehicle safety.
In support of its petition, Hankook offers the following reasoning:
1. The incorrect ply labeling information does not affect the operational safety of vehicles on which the tires are mounted.
2. The tires meet or exceed the performance requirements of FMVSS No. 139, and they otherwise comply with the labeling and performance requirements of FMVSS No. 139.
3. Hankook is not aware of any warranty claims, field reports, customer complaints, or any incidents, accidents, or injuries related to the subject condition.
4. Hankook cites the Transportation Recall, Enhancement, Accountability and Documentation (TREAD) Act (Pub. L. 106-414) and several of NHTSA's past grant notices of petitions for decisions of inconsequential noncompliance concerning the mislabeling of ply information and contend those are similar to the subject petition. Hankook states that NHTSA has routinely concluded the number of
Hankook argues that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
Hankook's complete petition and all supporting documents are available by logging onto the Federal Docket Management System (FDMS) website at:
NHTSA received one comment from the general public regarding Hankook's petition from Mr. Bruce Grim.
An important issue to consider in determining inconsequentiality is the safety risk to individuals who experience the type of event against which the recall would otherwise protect.
Arguments that only a small number of vehicles or items of motor vehicle equipment are affected have also not justified granting an inconsequentiality petition.
NHTSA has evaluated the merits of the inconsequential noncompliance petition submitted by the petitioner and agrees that, based on the facts presented, this specific noncompliance of the subject tires is inconsequential to motor vehicle safety. The Agency considered the following prior to making this determination:
1.
2.
3.
4.
5.
In summary, the Agency believes that the specific incorrect labeling of the tire construction information present in this instance will have an inconsequential effect on motor vehicle safety or any related downstream tire repair, retread, or recycling operations.
In consideration of the foregoing, NHTSA finds that Hankook has met its burden of persuasion that the subject FMVSS No. 139 noncompliance in the affected tires is inconsequential to motor vehicle safety. Accordingly, Hankook's petition is hereby granted and Hankook is consequently exempted from the obligation of providing notification of, and a free remedy for, that noncompliance under 49 U.S.C. 30118 and 30120.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject tires that Hankook no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve equipment distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant tires under their control after Hankook notified them that the subject noncompliance existed.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
Volkswagen Group of America, Inc. (Volkswagen), has determined that certain model year (MY) 2015-2016 Audi A3 and Audi S3 motor vehicles do not comply with Federal Motor Vehicle Safety Standard (FMVSS) No. 108,
Leroy Angeles, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), (202) 366-5304,
Notice of receipt of Volkswagen's petition was published with a 30-day public comment period, on July 9, 2019, in the
In support of its petition, Volkswagen offers the following reasoning:
(a) The driver receives two different indicator warnings that the rear brake light is inoperative in the instrument cluster immediately upon failure of the turn signal lamp to comply with the photometry requirements of FMVSS No. 108. This happens because the brake light and indicator light/turn signal are combined.
(b) The subject condition, the lack of a turn signal pilot indicator flash rate change, is limited to the condition in which the outermost left rear turn signal lamp fails.
(c) In the case of LED array failure, both the brake light and indicator light/turn signal become inoperative. Should the required left turn signal become inoperative, Volkswagen confirmed that other auxiliary left turn signal lights located on the trunk and the left side mirror are still operational. Additionally, the back-up lamp in the left rear tail lamp assembly, the left brake light in the trunk lid assembly, and the center high mount stop lamp, will remain operational.
Volkswagen concludes that the subject noncompliance is inconsequential as it relates to motor vehicle safety, and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
An important issue to consider in determining inconsequentiality based upon NHTSA's prior decisions on noncompliance issues was the safety risk to individuals who experience the type of event against which the recall would otherwise protect.
NHTSA has reviewed and evaluated the merits of the inconsequential noncompliance petition submitted by Volkswagen.
For this petition, NHTSA first considered the subject lamp configuration which consists of four light assemblies on the rear of the subject vehicles. Two outboard assemblies are mounted to the rear quarter panels and two inboard assemblies are mounted on the trunk lid. These pairs of assemblies, one on each side of the vehicle, are mounted adjacent to each other. When a turn signal is activated by the driver, the turn lamps in both the outboard and inboard assemblies on the side of the vehicle corresponding to the direction the driver selected, will illuminate. Volkswagen explained that that the auxiliary inboard lamps will remain operational should the outboard lamps become inoperative. The Agency did not find these factors to be compelling in granting this petition.
Instead, the Agency found the following considerations to be most relevant to its decision:
(a) While the turn signal pilot indicator does not change in flash rate when the left outboard turn signal lamp fails to meet the photometric requirements, the subject vehicles provide the drivers an alternative method of notification. According to Volkswagen's petition, the noncompliance in the subject vehicles is limited to when the left rear outboard turn signal lamp fails, and if the left inboard turn signal lamp should fail, the turn signal pilot indicator will function. Given these conditions, the noncompliance creates a scenario where a failure in the left outboard turn signal lamp will not activate the “fast flash” in the pilot indicator. While the driver is not alerted to a failure of the required turn signal lamp by means of a change in the flash rate of the turn signal pilot indicator lamp, if both the required turn signal lamp and the auxiliary turn signal lamp fails, the driver will be alerted by the means specified in the standard. In the event this inboard turn signal lamp should fail, the turn signal pilot indicator will alert the driver.
(b) In addition, Volkswagen has provided at least two other warning lights that illuminate to make the driver aware of the failure. A warning light will illuminate at vehicle start-up or when the failure occurs while driving. There will also be a constant bulb out indicator in the central information display while the turn signal lamp is inoperative. Additionally, if the left outboard turn signal lamp is out, all other required lamps still operate as designed.
In response to the public comment stating that “a redundancy should not be considered an appropriate substitute for a well-functioning, compliant failure indicator that's required by the FMVSS,” NHTSA agrees that an alternative method of notification is not a substitute for complying with a FMVSS. However, NHTSA has recently granted other petitions such as those submitted by Mack Trucks Inc. and Volvo Trucks North America where an alternative method of notification was a factor considered in granting the petition.
In the case of the subject petition, failure of the left rear outboard turn signal will result in the illumination of a steady burning general warning telltale, while a failure of the left rear inboard turn signal will produce a compliant “fast flash” warning. Thus, some form of notification will always result from a failure and an FMVSS No. 108-compliant warning will occur if both rear left turn signal lamps fail. Based on the specifics of this case, NHTSA believes this alternative warning provides adequate notice to drivers that the left rear turn signal lamp has failed such that this noncompliance is inconsequential to motor vehicle safety.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject vehicles that Volkswagen no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
Toyota Motor North America, Inc. (Toyota) has determined that certain Model Year (MY) 2013-2019 Toyota RAV4 and MY 2014-2019 Toyota Highlander/Highlander HV motor vehicles do not fully comply with S4 of Federal Motor Vehicle Safety Standard (FMVSS) No. 302,
Kelley Adams-Campos, Safety Compliance Engineer, Office of Vehicle Safety Compliance, NHTSA, 202-366-7479,
Toyota has determined that certain MY 2013-2019 Toyota RAV4 and certain Toyota Highlander/Highlander HV motor vehicles do not fully comply with paragraph S4 of FMVSS No. 302,
Notice of receipt of Toyota's petition was published with a 30-day public comment period, on December 3, 2019, in the
Approximately 2,144,217 MY 2013-2019 Toyota RAV4 and MY 2014-2019 Toyota Highlander/Highlander HV motor vehicles manufactured between December 21, 2012, and March 28, 2019, are potentially involved.
Toyota explains that the noncompliance relates to certain hook and loop fasteners that attach the floor carpet to the underlying padding. The loop side of the fastener is made from material that may not comply, as required, with paragraph S4.1 of FMVSS No. 302. Specifically, when tested separately from the floor carpet, the loop side of the fastener in the subject vehicles does not meet the burn rate requirements of paragraph S4.3.
Paragraphs S4.1 through S4.3(b) of FMVSS No. 302 include the requirements relevant to this petition:
S4.1 The portions described in S4.2 of the following components of vehicle occupant compartments shall meet the requirements of S4.3: Seat cushions, seat backs, seat belts, headlining, convertible tops, armrests, all trim panels including door, front, rear, and side panels, compartment shelves, head restraints, floor coverings, sun visors, curtains, shades, wheel housing covers, engine compartment covers, mattress covers, and any other interior materials, including padding and crash-deployed elements, that are designed to absorb energy on contact by occupants in the event of a crash.
S4.2.1 Any material that does not adhere to other material(s) at every point of contact shall meet the requirements of S4.3.
Paragraph S4.3(a) of FMVSS No. 302 requires that material described in S4.1 and S4.2 shall not burn, nor transmit a flame front across its surface, at a rate of more than 102 mm per minute. The requirement concerning the transmission of a flame front shall not apply to a surface created by cutting a test specimen for purposes of testing pursuant to S5.
The following views and arguments presented in this section (V. Summary of Toyota's Petition), are the views and arguments provided by Toyota.
Toyota described the subject noncompliance and stated its belief that the noncompliance is inconsequential as it relates to motor vehicle safety. In support of its petition, Toyota submitted the following:
1. During pre-production evaluations of the new model Highlander (MY 2020) the supplier found that the loop fasteners might not meet the burn rate requirement of FMVSS No. 302. These same fasteners are used on the subject vehicles; they are attached to the underside of the carpet near the front footwell. Toyota conducted testing of the loop side of the fastener, in accordance with FMVSS No. 302; when tested separately from the carpet, the burn rate of the loop side of the fastener was 133 mm/min (worst of ten tests). The loop fastener material did not have flame-retardant coating, and therefore the burn rate requirement specified on the drawing was not met.
2. The loop fastener material complies with FMVSS No. 302 when tested as a “composite” as installed to the FMVSS No. 302 compliant carpet assembly.
3. The purpose of FMVSS No. 302 is to “reduce the deaths and injuries to motor vehicle occupants caused by vehicle fires, especially those originating in the interior of the vehicle from sources such as matches or cigarettes.” The noncomplying loop fastener material would normally not be exposed to open flame or an ignition source (like matches or cigarettes) in its installed application, because it is installed beneath and completely covered by the carpet material which complies with FMVSS No. 302.
4. The loop fastener material is a very small portion of the overall mass of the soft material portions comprising the carpet assembly (
5. Toyota is not aware of any data suggesting that fires have occurred in the field from installation of the noncomplying loop fastener material.
• Toyota says NHTSA has previously granted at least ten FMVSS No. 302 petitions for inconsequential noncompliance—one of which was for a vehicle's seat heater assemblies, one of which was for a vehicle's console armrest, one of which was for large truck sleeper bedding, one of which was for seating material, and six of which were for issues related to child restraints systems (CRS). These are:
• Paccar (57 FR 45868, October 5, 1992)—Noncompliant tape edging surrounding otherwise compliant bedding materials in a large truck sleeper bed was deemed by the Agency to be inconsequential given its low relative volume to the otherwise complying surrounding material, as well as the fact the tape edging passed bedding industry fire standards. Unlike the Toyota loop fastener material in the subject vehicles, which is not exposed directly to the occupant compartment air space, the tape edging of the sleeper bed was exposed. Nonetheless, the Agency granted the petition on the basis that the noncompliant material was surrounded by compliant material and was of a low relative volume compared to the compliant material.
• Fisher-Price (60 FR 41152, August 11, 1995)—Noncompliant fabric used in CRS shoulder straps was deemed to be inconsequential by the Agency, due to factors which included that the margin of noncompliance was small; the shoulder straps that do not comply are a small part of the CRS itself and a minimal part of the fabric present in a vehicle's interior; the absence of reports in which the noncompliance exists supported the Agency's decision that the noncompliance is inconsequential. Toyota stated that the Toyota loop fastener material is also a small part of the vehicle carpet and a minimal part of the materials in the interior of the subject vehicles.
• Century (60 FR 41148, August 11, 1995)—Noncompliant seat covers were determined unlikely to pose a flammability risk when securely sewn to the seat (
• Cosco—(60 FR 41150, August 11, 1995)—Noncompliant fabric used in CRS shoulder straps was deemed to be inconsequential by the Agency due to the similarity to the Fisher-Price request for inconsequentiality and the reasons set out in the notice granting Fisher Price's appeal (see above). FMVSS No. 302 does not in itself apply to child restraint systems, but paragraph S4 of FMVSS No. 302 is invoked by reference in FMVSS No. 213; therefore, the child restraint petitions are relevant precedents.
• Kolcraft (63 FR 24585, May 4, 1998)—One or more of the fitting, face, or backing materials of CRS seat covers were noncompliant. NHTSA determined the noncompliance to be inconsequential because when tested as a composite (
• Cosco (63 FR 30809, June 5, 1998)—NHTSA found that the noncomplying fiberfill incorporated into a pillow located in a child restraint was inconsequential to safety due to the unlikelihood of exposure to an ignition source for various reasons: That the noncompliant material was encased in materials which complied with FMVSS No. 302, and that the fiberfill was only a limited quantity of noncompliant material used in the CRS. Similarly, the subject Toyota loop fastener material also passes the FMVSS No. 302 requirements when tested as a composite, is unlikely to be exposed to a direct ignition source, is surrounded by materials which comply with FMVSS No. 302, and is only a limited quantity of noncompliant material in the carpet assembly. The Agency also noted that (as is the case with the subject Toyota loop material) “the absence of fires originating in these child restraints supported the Agency's decision that the noncompliance does not have a consequential effect on safety.”
• Ford (63 FR 40780, July 30, 1998)—A noncompliant center console armrest “plus pad” was determined by the Agency to be inconsequential to safety in that, because of its location under an exterior cover, it was unlikely to pose a flammability risk due to the unlikelihood of its exposure to an ignition source. The Agency was unaware of any occupant injuries in vehicle post-crash fires that were caused by burning of the console armrests in those vehicles. Toyota argued that Ford undertook “composite” testing like Toyota's described above to support its petition.
• Graco (77 FR 14055, March 8, 2012)—Certain noncompliant warning labels attached to the outside of detachable accessory pillows were deemed inconsequential by the Agency due to the relatively small size of the label, together with its proximity to other materials on the CRS that were treated with flame retardant materials, rendering the likelihood of ignition of the label extremely low. The subject Toyota loop fastener material is surrounded by compliant materials, is not exposed to the occupant compartment air space, and is a small part of the vehicle carpet assembly and a minimal part of the otherwise compliant materials in the interior of the subject vehicles.
• Toyota (80 FR 4035, January 26, 2015)—Certain noncompliant front and rear seat back and seat cushion seat heaters were determined by the Agency to be inconsequential to safety in that the seat heaters were unlikely to pose a flammability risk. The Agency was unaware of any occupant injuries regarding these seat heaters in the subject vehicles. The seat heaters would not accommodate a flame rate beyond what is permitted by FMVSS No. 302 when exposed directly to an open flame in the installed condition (as a composite). It was also demonstrated that the seat heater was a very small portion of the overall mass of the seat assembly. According to Toyota, the facts here are similar. The subject loop fastener material is unlikely to be exposed to an ignition source in the installed condition, it does not accommodate a flame beyond what is permitted by FMVSS No. 302 when exposed directly to an open flame in the installed condition (as a composite), the loop material is only a very small portion of the overall mass of the carpet assembly, and there are no known field ignition events.
• Toyota (83 FR 16433, April 16, 2018)—Certain noncompliant needle punch felt material used in the front and rear seat covers and rear center armrest assemblies was determined by the Agency to be inconsequential to safety. The Agency stated that: (1) The needle punch felt material is covered by other materials that do comply with FMVSS No. 302, thus, the needle punch felt material is protected from the occupant compartment where it could directly come into contact with an ignition source such as a match or cigarette; (2) when the needle punch felt material is tested as a composite with the FMVSS No. 302 compliant materials (
Toyota concluded that the subject noncompliance is inconsequential as it relates to motor vehicle safety and that its petition to be exempted from providing notification of the noncompliance, as required by 49 U.S.C. 30118, and a remedy for the noncompliance, as required by 49 U.S.C. 30120, should be granted.
NHTSA has reviewed Toyota's evaluation that the subject noncompliance is inconsequential to motor vehicle safety. The burden of establishing the inconsequentiality of a failure to comply with a performance requirement in a standard—as opposed to a labeling requirement—is more substantial and difficult to meet. Accordingly, the Agency has not found many such noncompliances inconsequential.
An important issue to consider in determining inconsequentiality based
NHTSA considered the following factors in evaluating this petition:
First, according to the data provided by Toyota, the noncompliant material has a mass that is insignificant when compared to the overall mass of the carpet assembly. The petitioner stated that the mass of the loop fastener constitutes approximately 0.037 percent or less of the soft material portions of the carpet assembly. However, while Toyota argues that the noncompliant material would not significantly fuel a fire, should it become exposed, the relative measure,
Second, the loop fastener material in the subject vehicles is covered by the carpet material which complies with FMVSS No. 302, thus, the loop fastener material is protected from contact with an ignition source originating from the occupant space.
Third, the data submitted by Toyota shows that, when tested as a single unit, the loop fasteners along with the carpet comply with FMVSS No. 302.
Toyota also stated that NHTSA has granted previous petitions whose facts align with those at issue in the instant case. These include a Paccar petition (57 FR 45868, October 5, 1992), a Fischer Price (60 FR 41152, August 11, 1995) petition, a Century petition, (60 FR 41148, August 11, 1995), Kolcraft (63 FR 24585, May 4, 1998), Cosco petition (60 FR 41150, August 11, 1995) and a Toyota petition (80 FR 4035, January 26, 2015) where the non-compliant material represented a small percentage of the interior fabric. As NHTSA states previously in this section, the relative measure,
NHTSA finds that Toyota has met its burden of persuasion of demonstrating that the noncompliant small loop fasteners sewn into the carpet at issue in this case do not present a risk to safety. The noncompliant fabric present here must be separated from the carpet to be deemed noncompliant as the carpet and loop patch together meet the standard. The loop fasteners also constitute a small percentage of the fabric area and are located where they are not likely to encounter an ignition source. Accordingly, Toyota's petition is hereby granted. Toyota is consequently exempted from the obligation of providing notification of, and a free remedy for, the noncompliance under 49 U.S.C. 30118 and 30120.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject vehicles that Toyota no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant vehicles under their control after Toyota notified them that the subject noncompliance existed.
Departmental Offices, U.S. Department of the Treasury.
Notice.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to comment on the proposed information collections listed below, in accordance with the Paperwork Reduction Act of 1995.
Written comments must be received on or before March 22, 2022.
Send comments regarding the burden estimate, or any other aspect of the information collection, including suggestions for reducing the burden, by the following method:
•
For questions related to these programs, please contact Guizelous Molock by emailing
Department of the Treasury.
Notice.
Pursuant to section 70913 of the Infrastructure Investment and Jobs Act, the Department of the Treasury has prepared the report provided below regarding its financial assistance programs that provide funding that may be used by recipients for infrastructure projects.
For further information about the programs administered by the Office of Recovery Programs, contact Brette Fishman, Director, Office of Grant Policy, Office of Recovery Programs, at
For further information about the RESTORE Act, Direct Component program administered by the Office of Gulf Coast Restoration, contact Maureen Klovers, Program Director, Office of Gulf Coast Restoration at
On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (IIJA), which includes the “Build America, Buy America Act” (the Act). This Act ensures that Federal infrastructure programs require the use of materials produced in the United States, increases the requirement for American-made content, and strengthens the waiver process associated with Buy America provisions.
The Act requires that within 60 days of its enactment, January 14, 2022, each agency must submit to the Office of Management and Budget (OMB) and Congress and publish in the
In an effort to aid agencies towards compliance with Sections 70913 (Identification of Deficient Programs) and 70914 (Application of Buy America Preference) of the IIJA, OMB issued memorandum M-22-08,
OMB memorandum M-22-08 also informs agencies regarding items that are required to be contained in the 60-
This report errs on the side of over-inclusiveness, given the requirement to submit this report at this time. As instructed by OMB, Treasury has included all programs for which funds may be obligated for infrastructure under any award. After OMB releases implementation guidance as outlined in Section 70915 of the IIJA, Treasury will re-evaluate its identification of agency programs that are subject to Build America, Buy America requirements.
Treasury's main organizational components that provide financial assistance include: The Internal Revenue Service and the Departmental Offices (including the Community Development Financial Institutions Fund and the Office of Recovery Programs (ORP)). Of those components, based on program analysis, only DO has Federal financial assistance programs related to infrastructure that merit inclusion in the 60-day report. This section identifies and describes the active programs applicable to the IIJA.
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•
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Table 3-1 depicts the deficiency status of each Treasury financial assistance infrastructure program, as it relates to Section 70914
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
Veterans Benefits Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before March 22, 2022.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Maribel Aponte, Office of Enterprise and Integration, Data Governance Analytics (008), 1717 H Street NW, Washington, DC 20006, (202) 266-4688 or email
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Final rule.
FMCSA amends its regulations to permit individuals who do not satisfy, with the worse eye, either the existing distant visual acuity standard with corrective lenses or the field of vision standard, or both, to be physically qualified to operate a commercial motor vehicle (CMV) in interstate commerce under specified conditions. Currently, such individuals are prohibited from driving CMVs in interstate commerce unless they obtain an exemption from FMCSA. The new alternative vision standard replaces the current vision exemption program as the basis for determining the physical qualification of these individuals.
This final rule is effective March 22, 2022.
Comments on the information collections in this final rule must be submitted to the Office of Information and Regulatory Affairs (OIRA) at the Office of Management and Budget (OMB) by February 22, 2022.
Petitions for Reconsideration of this final rule must be submitted to the FMCSA Administrator no later than February 22, 2022.
Comments and recommendations for the information collections should be sent within 30 days of publication of this final rule to
Ms. Christine A. Hydock, Chief, Medical Programs Division, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, (202) 366-4001,
FMCSA organizes this final rule as follows:
To view any documents mentioned as being available in the docket or comments received, go to
FMCSA amends its regulations to permit an individual who does not satisfy, with the worse eye, either the existing distant visual acuity standard with corrective lenses or the field of vision standard, or both, to be physically qualified to operate a CMV in interstate commerce under specified conditions. The individual must satisfy the new alternative vision standard, along with FMCSA's other physical qualification standards. In addition, with limited exceptions, individuals physically qualified under the alternative standard for the first time must satisfactorily complete a road test administered by the employing motor carrier before operating a CMV in interstate commerce. This rule eliminates the need for the current Federal vision exemption program, as well as the grandfather provision in 49 CFR 391.64 for drivers operating under the previously administered vision waiver study program. The alternative vision standard enhances employment opportunities while remaining consistent with FMCSA's safety mission.
This rule establishes an alternative vision standard, as proposed in the NPRM (86 FR 2344 (Jan. 12, 2021)), with minor clarifications. The final rule clarifies that the alternative vision standard is applicable to individuals who do not satisfy, with the worse eye, the existing FMCSA distant visual acuity standard with corrective lenses or the field of vision standard, or both.
The alternative vision standard is comparable to the regulatory framework FMCSA adopted in § 391.46 for individuals with insulin-treated diabetes mellitus (see 83 FR 47486 (Sept. 19, 2018)). The alternative vision standard takes the same collaborative
Before an individual may be medically certified under the alternative vision standard, the individual must have a vision evaluation conducted by an ophthalmologist or optometrist. The ophthalmologist or optometrist records the findings of the vision evaluation and provides specific medical opinions on the new Vision Evaluation Report, Form MCSA-5871. Then, an ME performs a physical qualification examination and determines whether the individual meets the alternative vision standard, as well as FMCSA's other physical qualification standards. If the ME determines the individual meets the physical qualification standards, the ME may issue a Medical Examiner's Certificate (MEC), Form MCSA-5876, for a maximum of 12 months.
In making the physical qualification determination, the ME considers the information in the Vision Evaluation Report, Form MCSA-5871, and utilizes independent medical judgment to apply the following four standards. The new alternative vision standard provides that, to be physically qualified, the individual must: (1) Have, in the better eye, distant visual acuity of at least 20/40 (Snellen), with or without corrective lenses, and field of vision of at least 70 degrees in the horizontal meridian; (2) be able to recognize the colors of traffic signals and devices showing standard red, green, and amber; (3) have a stable vision deficiency; and (4) have had sufficient time pass since the vision deficiency became stable to adapt to and compensate for the change in vision. FMCSA clarifies in the last of the four standards that there must be a period for the individual to adapt to and compensate for the vision loss after the vision deficiency is deemed stable by a medical professional.
Subject to limited exceptions, individuals physically qualified under the alternative vision standard for the first time must satisfactorily complete a road test before operating in interstate commerce. The employing motor carrier conducts the road test in accordance with the road test already required by § 391.31. Individuals are excepted from the road test requirement if they have 3 years of intrastate or specific excepted interstate CMV driving experience with the vision deficiency, hold a valid Federal vision exemption, or are medically certified under the previously administered vision waiver study program in § 391.64(b).
This rule takes a more individualized approach to medical certification than the vision exemption program it replaces and ensures that individuals medically certified under the alternative vision standard are physically qualified to operate a CMV safely. The process creates a clear and consistent framework to assist MEs with the physical qualification determination that is equally as effective as a program based on considering exemptions under 49 U.S.C. 31315(b). In addition, the approach of MEs making the physical qualification determination, instead of FMCSA as in the current exemption program, is consistent with Congress' directive in 49 U.S.C. 31149(d) for trained and certified MEs to determine the individual's physical qualification to operate a CMV.
The alternative vision standard replaces the current vision exemption program as the basis for determining the physical qualification of individuals to operate a CMV. Accordingly, the 1,967 current vision exemption holders
Similarly, the approximately 1,800 individuals currently physically qualified under the grandfather provisions in § 391.64(b)
FMCSA estimates this rule will reduce barriers to entry, thereby increasing employment opportunities, for current and future CMV drivers. The 1,967 drivers holding vision exemptions will no longer have to apply for an exemption, and potential drivers who would not qualify for an exemption because they do not have 3 years of intrastate driving experience may meet the alternative vision standard and be able to operate a CMV in interstate commerce. Additionally, previously qualified interstate CMV drivers who no longer satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or field of vision standard, or both, will be able to return sooner than 3 years to operating in interstate commerce. These drivers are also relieved of the time and paperwork burden associated with applying for or renewing an exemption.
FMCSA has authority under 49 U.S.C. 31136(a) and 31502(b)—delegated to the Agency by 49 CFR 1.87(f) and (i),
In addition to the statutory requirements specific to the physical qualifications of CMV drivers, section 31136(a) requires the Secretary of Transportation (Secretary) to issue regulations on CMV safety, including regulations to ensure that CMVs “are maintained, equipped, loaded, and operated safely” (section 31136(a)(1)). The remaining statutory factors and requirements in section 31136(a), to the extent they are relevant, are also satisfied here. The final rule does not impose any responsibilities on CMV drivers that “impair their ability to operate the vehicles safely” (section 31136(a)(2)), or “have a deleterious effect on the physical condition” of CMV drivers (section 31136(a)(4)). FMCSA does not anticipate that drivers will be coerced to operate a vehicle because of this rule (section 31136(a)(5)).
Additionally, in 2005, Congress authorized the creation of the Medical Review Board (MRB), comprised of experts in a variety of medical specialties relevant to the driver fitness requirements, to provide medical advice and recommendations on physical qualification standards (49 U.S.C. 31149(a)). The position of Chief Medical Examiner was authorized at the same time (49 U.S.C. 31149(b)). Under section 31149(c)(1), the Agency, with the advice of the MRB and Chief Medical Examiner, is directed to establish, review, and revise medical standards for CMV drivers that will ensure their physical condition is adequate to enable them to operate the vehicles safely (see also 49 U.S.C. 31149(d)). Finally, the Secretary has discretionary authority under 49 U.S.C. 31133(a)(8) to prescribe recordkeeping and reporting requirements.
FMCSA has considered the costs and benefits associated with this final rule (49 U.S.C. 31136(c)(2)(A) and 31502(d)). Those factors are discussed in the Regulatory Analyses section of this rule.
On January 12, 2021, FMCSA published an NPRM titled “Qualifications of Drivers; Vision Standard” (86 FR 2344). The NPRM included a detailed discussion of the background and regulatory history for this action, including the existing vision standard, the vision waiver study program and grandfathered drivers, and the Federal vision exemption program. It also included a discussion of the reports and analyses undertaken since 1990 to gather information and evaluate the vision standard, the vision waiver study program, and the vision exemption program, as well as the MRB recommendations pertaining to vision and FMCSA's conclusions regarding those reports and analyses. While not repeated here, these discussions can be found in the NPRM (86 FR 2348-56).
A detailed discussion of the rationale for the proposed alternative vision standard is set forth in the NPRM (86 FR 2356-61) and will not be repeated here. Summaries of the relevant provisions of the NPRM are included in the discussion of the comments below. The NPRM's comment period closed on March 15, 2021.
The NPRM provided that following the closure of the comment period FMCSA would ask the MRB to review all comments from medical professionals and associations. Accordingly, in May 2021, FMCSA requested in MRB Task 21-1 that the MRB review and analyze the nine comments from medical professionals and associations, make recommendations regarding the proposed alternative vision standard, and identify factors the Agency should consider regarding next steps in the vision rulemaking. In addition, FMCSA requested the MRB's recommendations with respect to whether the information requested from ophthalmologists and optometrists on the proposed Vision Evaluation Report, Form MCSA-5871, provided sufficient information for an ME to make a medical certification determination.
In May 2021, the MRB held a public meeting to consider MRB Task 21-1, among other topics. On July 20, 2021, the MRB provided its recommendations to FMCSA in MRB Task Report 21-1.
A. With respect to the medical aspects of the proposed alternative vision standard only, if the MRB does not make a specific recommendation to change a provision, the MRB concurs with the provision as proposed in the January 2021 NPRM.
B. The MRB recommends that the Agency deemphasize that the alternative vision standard begins with the vision evaluation because the individual may be examined first by the medical examiner.
A. The MRB recommends that the current field of vision requirement be changed from 70 degrees to 120 degrees for the alternative vision standard for monocular vision drivers.
B. The MRB agrees that the requirement for sufficient time to adapt to and compensate for the vision deficiency should not be changed in the proposed alternative vision standard. The MRB notes it does not have sufficient data to establish a specific waiting period for an individual who has a new vision deficiency.
A. The MRB recommends that the physical qualification standards for the alternative vision standard, as set forth in the paragraph below from Task 21-1 but modified to reflect a field of vision of at least 120 degrees, be added to page 1 in the instructions after FMCSA's definition of monocular vision:
The proposal would provide that, to be physically qualified under the alternative vision standard, the individual must: (1) Have in the better eye distant visual acuity of at least 20/40 (Snellen), with or without corrective lenses, and field of vision of at least 120 degrees in the horizontal meridian; (2) be able to recognize the colors of traffic signals and devices showing standard red, green, and amber; (3) have a stable vision deficiency; and (4) have had sufficient time to adapt to and compensate for the vision deficiency.
B. The MRB recommends that the Agency expand the medical opinion in question 12 to require that the individual can drive a CMV safely with the vision condition. The MRB notes that the medical opinion provided by the ophthalmologist or optometrist regarding whether the individual has adapted to and compensated for the change in vision sufficiently encompasses depth perception. The MRB notes further that question 12 sufficiently implies that time is needed to adapt and compensate for the change in vision but appropriately relies on the ophthalmologist or optometrist conducting the vision evaluation to determine the appropriate period of time on a case-by-case basis.
C. The MRB recommends that the requests for information about stability in questions
D. The MRB recommends that the Agency change the order of the requested information to be questions 1 through 9, 10, 12, 13, and then 11.
E. The MRB recommends that the vision evaluation report not request information relating to severe non-proliferative diabetic retinopathy and proliferative diabetic retinopathy because they are evaluated separately under the standard for insulin-treated diabetes mellitus.
On August 24, 2021, FMCSA published a notice of availability (NOA) of the MRB's recommendations in the
In this final rule, FMCSA responds to public comments to the NPRM and the NOA regarding the recommendations in the MRB Task 21-1 Report.
In response to the NPRM, FMCSA received 69 submissions. One submission was identified as not relevant, two submissions were duplicates, and one commenter provided two different submissions. Accordingly, 65 commenters (primarily individuals) provided responsive comments to the NPRM. The commenters were healthcare providers, one medical association, drivers, motor carriers, two trade associations, and private citizens. Fourteen commenters were anonymous. No safety organizations commented on the NPRM.
The majority of commenters (45) expressed general support for the proposed rule. These commenters included a board-certified retina surgeon and ophthalmologist, two MEs, CMV drivers with either Federal vision exemptions or State vision waivers, former drivers who no longer satisfy the vision standard, individuals who have not had the opportunity to drive a CMV because of their vision, the Owner-Operator Independent Drivers Association (OOIDA), and individuals who viewed the rule as reducing discrimination. Common reasons cited for supporting the proposal include the following: The evidence shows monocular drivers are safe and have no adverse impact on safety; the rule would remove barriers to entry, create job opportunities, encourage more individuals to enter the workforce, keep experienced drivers, and reduce the driver shortage; the rule is modeled on the approach used to eliminate the exemption program and create an alternative physical qualification standard for insulin-treated diabetes mellitus that has worked well; the rule would be a step toward less discrimination and more inclusion in the workforce; and the proposed standard is more streamlined than the exemption process so it would decrease time and paperwork burdens for drivers.
Twenty commenters generally opposed the proposed rule (including commenters who supported the proposal in concept but wanted further study before implementing it). These commenters included four MEs, the American College of Occupational and Environmental Medicine (ACOEM), Concentra (a healthcare company that delivers occupational medicine and urgent care services to employers and patients), two drivers, and the American Trucking Associations, Inc. (ATA). Common reasons cited for opposing the proposal include the following: The proposal fails to demonstrate an appropriate level of safety or the data is inconclusive on safety; findings from drivers enrolled in the waiver and exemption programs cannot be applied to the general population of drivers; the road test is not a suitable alternative to 3 years of driving experience and places a burden on motor carriers; the field of vision requirement should be greater than 70 degrees; and the MRB has not recommended changes to the vision standard.
In response to the NOA on the MRB Task 21-1 Report, FMCSA received 14 submissions. The commenters were one ME, one medical association, drivers and individuals with vision loss in one eye, one motor carrier, one trade association, private citizens, and five anonymous commenters. No safety organizations commented on the NOA.
The NOA stated that “Comments must be limited to addressing the recommendations in the MRB Task 21-1 Report” (86 FR 47279). Only four commenters provided comments that were responsive, at least in part, to the MRB recommendations. Five commenters provided general support for the alternative vision standard. Two commenters opposed the new vision standard. Three comments were outside the scope of the rulemaking.
The MRB's recommendations and public comments responsive to them are addressed where applicable in the discussion of comments and responses below.
Accordingly, FMCSA found the experience with the vision waiver study and exemption programs to be most relevant in establishing an alternative vision standard. Based on that experience, FMCSA determined the safety performance of the individuals in the vision waiver study and vision exemption programs is at least as good as that of the general population of CMV drivers. FMCSA stated that, if an individual meets the proposed alternative vision standard, the Agency expects there will be no adverse impact on safety due to the individual's vision.
A commenter who is an ME and has examined a moderate number of drivers with monocular vision stated that they have adapted to the monocular vision and “have been driving professionally successfully.” The commenter referred to an August 2005 abstract published in
OOIDA stated that the “research presented demonstrates that individuals with monocular vision can safely operate a CMV.” OOIDA stated further that “There is also considerable medical literature indicating that individuals with vision loss in one eye can and do develop compensatory viewing behavior to mitigate their vision loss.” OOIDA commented that the alternative vision standard “ensures sufficient physical qualifications are met.”
Three commenters stated studies show the alternative vision standard will not compromise safety. A different commenter stated, “There is no factual evidence to support the idea that reduced vision has a negative impact on driving abilities.” Another commenter, a motor carrier, also commented that the alternative vision standard would not increase danger to the public.
A commenter stated the alternative vision standard “comports with current scientific findings” and “is not arbitrary, . . . It is based on actual reports from credentialed professionals.” The commenter noted that “safeguards will be in place to catch and mitigate any safety issues.” For example, an ME makes the vision determinations instead of an FMCSA employee. The road test ensures a driver operating under the alternative vision standard can physically drive the CMV safely. Finally, the proposed 12-month maximum certification period ensures a driver will be re-evaluated in a year to determine continued eligibility for CMV driving.
A commenter who holds a Federal vision exemption stated individuals who have had time to adapt and “compensate for their deficiency are, indeed, safer and more conscientious than your average driver.” Several other commenters who hold intrastate vision waivers noted their safe driving records or that their vision does not hinder them in any way. They stated it does not make sense that they can drive in intrastate commerce but not in interstate commerce. A commenter, who has always had monocular vision and has a “terrific driving record,” stated “Having one eye increases your awareness of the need to be diligent about your surroundings.”
In contrast, ACOEM and Concentra commented that the studies cited are inconsistent in the definition of the conditions studied (
Concentra commented that one of the rebuttals to its concerns will be that there have not been any significant problems with monocular drivers in the last 30 years. It stated this “could lead one to conclude drivers with monocular vision are as safe as other drivers.” Concentra reminded readers that data is either absent or conflicting regarding the safety of monocular drivers. Additionally, with such a small percentage of drivers having monocular vision, Concentra stated the “data will continue to be difficult to obtain in a statistically significant manner.”
Two commenters, who are medical doctors and MEs, stated that the existing vision standard should not be changed. One stated that the existing standard is loose enough as it is. The other added that, as a criterion for safe driving, it is imperative to have acuity in vision to drive a multi-ton vehicle around other drivers and pedestrians on the road. A commenter agreed with the doctors, stating that when it comes to public safety individuals with vision impairments should not drive CMVs because the impairments affect their capabilities. A different commenter who is an ME expressed “concern about changing the vision requirements.”
ATA commented that since 1992 it has consistently objected to loosening the vision standard in the absence of robust data showing such revisions would not deteriorate the current level of safety. ATA stated it “has consistently advocated that a revised but universally applied vision standard would be superior to the current exemption program and the inconsistency that results from its ad hoc application.” ATA noted that its “members accept FMCSA's analysis that the Agency `has observed no adverse impact on CMV safety due to the vision exemption program.'” However, ATA continued that it “strongly objects to FMCSA's use of the federal vision exemption program data without factoring in the safety implications of removing essential safeguards contained within the program to warrant the proposed revision to the vision standard.” ATA stated that “FMCSA's NPRM fails to propose a standard that would demonstrably maintain the appropriate level of safety.”
Three commenters recommended that FMCSA undertake further studies before proposing an alternative vision standard. The first commenter stated: (1) The statement about vision data from the “Visual Requirements and Commercial Drivers” report supports maintaining the current requirements for overall safety; (2) the MRB recommended in 2008 that the vision standard should not be changed; and (3) the 2008 evidence report summarized that the data was not conclusive to determine crash risk so more study is required. The commenter noted that the accident rate study conducted from August 1992 to November 1995 found the accident rates of both the waiver group and control group were significantly better/lower than that of the national rates because both groups were being monitored. The commenter stated that one can infer that if all CMV drivers were in a similar monitoring program then the overall national accident rates would follow this reduced accident rate trend and improve overall safety. The commenter also stated that, before any reduction to existing vision standards can occur, all relevant data must be evaluated through consistent methodologies (
One commenter noted a finding in the November 2016 Analysis Brief that the crash rate of vision exemption drivers was statistically different and higher than the crash rate in the control group. That commenter “would feel safer if the vision standards became a little stricter for CMVs.”
Another commenter stated the proposed amendment finds “the perfect balance between the correct qualification need for these individuals and road safety.” The commenter continued that modification of the existing vision standard is needed and the proposal seems to provide a framework for who ensures proper evaluation and criteria are met. However, the commenter noted the need to remain vigilant of the data presented because of inconsistencies among studies and “limitations in regard to our populations.”
A commenter, who acknowledged not reading the reports discussed in the NPRM, stated that as a safety-minded professional the commenter saw “the reduced standards as a gateway for more accidents.” The commenter asked, if FMCSA has data to indicate drivers with vision exemptions had no significant issues, is it possible the data was based on limited markets where drivers operated in areas with less traffic. The commenter concluded that the alternative vision standard “will have a profound impact on public safety” and “hope[d] the FMCSA discards this NPRM in the interest of public safety.”
Several additional commenters opposed the alternative vision standard based on general safety concerns. For example, one commenter stated, while agencies are working to get more drivers on the road and make it easier for drivers to obtain their Federal medical certification, “there should remain certain criteria for obvious safety reasons.” The commenter continued that an amendment to the vision standard would not be in the best interest of the driver or the public on the road. Similarly, a different commenter noted the rule would be effective in creating more job opportunities and saving a big amount of money but did “not think that this rule is effective in ensuring roads are safe for every driver.” Another commenter stated our roads are dangerous enough already and did not want people with vision impairments on the road. One commenter, who has been driving for more than 34 years, stated the vision standards should be left alone. Finally, another commenter stated that FMCSA needs to be more worried about other issues and that the existing standard is not a cause in that many accidents.
The Agency acknowledges, as it did in the NPRM, that the data on the relationship between monocular vision and crash involvement is sparse, conflicting with respect to crash risk, and not definitive. It does not establish strong relationships between specific measures of vision and their correlation to driver safety. FMCSA also acknowledges that different definitions of “monocular vision” are used in the literature. These limitations in studies relating to crash risk explain why the Agency elects to rely on its long experience with the vision waiver study and exemption programs as a basis for this rule in addition to the medical literature.
Further studies evaluating the impact of a vision deficiency in one eye on driving performance are unnecessary for the purposes of this rule. Considering the long period over which the vision waiver and exemption programs have operated, the Agency has sufficient information and experience to reach generalized conclusions. The experience with the programs has allowed FMCSA to evaluate the vision criteria used in the programs since 1992 and adopted in this rule in the context of actual CMV driving experience. Contrary to the implication by one commenter, FMCSA finds no basis for the assertion that the experience of drivers in the programs occurred in limited markets with less traffic.
FMCSA disagrees that the experience and safety determinations based on the vision waiver study and exemption programs cannot be applied to the alternative vision standard. To isolate the impact of a vision deficiency on driving, the Agency excluded drivers with a history of unsafe driving behaviors. After 30 years of experience with the vision waiver study and exemption programs, FMCSA finds it is reasonable to conclude that, if the vision deficiency had an adverse impact on the ability to operate a CMV, there would be observed evidence of that adverse impact over the long period, even though the individuals were generally safe drivers, experienced in driving with the vision deficiency, or monitored. FMCSA has no such evidence.
One commenter noted a finding in the November 2016 Analysis Brief that the crash rate of vision exemption drivers was statistically different and higher than the crash rate in the control group. As FMCSA explained in the NPRM, that finding is not cause for concern. The findings of the Analysis Brief represent a limited period and are subject to several limitations. In particular, the crash information did not consider whether the CMV driver was at fault in any given crash. Moreover, it is not possible to know whether visual function caused or contributed to the crash. FMCSA monitors the performance of individual drivers in the vision exemption program continuously. FMCSA has no evidence to suggest drivers in the exemption program are less safe than the general population of CMV drivers.
Another commenter stated that the August 1992 to November 1995 study found the accident rates of the waiver group and control group were significantly lower than that of the national rate. The commenter inferred that was because the wavier and control groups were monitored in some manner. The Agency clarifies that study did not include a control group. The comparison was of the accident rate in the waiver group to the national rate.
FMCSA disagrees that the alternative vision standard presents a “loosening” or “reduction” in vision standards. The Agency finds, as did Dr. Morris, that the requirements adopted are appropriate and will not adversely impact safely. The rule allows individuals who have developed the skills to adapt to and compensate for the vision loss to demonstrate that they also have the skills to operate a CMV safely. The rule includes safeguards to ensure that only individuals who have developed the skills to adapt to and compensate for the vision loss will be physically qualified.
As compared to the existing physical qualification process, individuals physically qualified under the alternative vision standard are subject to more stringent requirements. Individuals physically qualified under the existing vision standard undergo only a basic vision screening test performed by MEs at least once every 2 years. Individuals physically qualified under the alternative vision standard must undergo a thorough eye evaluation conducted by an ophthalmologist or optometrist using sophisticated equipment at least once a year. As discussed further below, the ophthalmologists and optometrists performing the evaluations are to provide their medical opinions regarding whether the individuals evaluated have adapted to and compensated for the change in vision such that they can drive a CMV safely with the vision deficiency. Moreover, individuals physically qualified under the alternative vision standard must undergo a physical qualification examination at least once a year.
As compared to the case-by-case determinations made in the exemption program, the alternative vision standard provides a consistent approach to medical certification of individuals who do not meet the existing vision standard. This approach of MEs making the physical qualification determination, instead of FMCSA, as in the exemption program, is consistent with Congress' directive in 49 U.S.C. 31149(d) for trained and certified MEs to assess the individual's health status.
Comments on
ATA cautioned “that deemphasizing the two-step process might result in additional burdens for a driver who would need to make multiple visits to a medical examiner.” ATA emphasized that individuals who know they will be physically qualified under the alternative vision standard should see the vision specialist first. However, if a driver is evaluated by an ME first and subsequently referred to a vision specialist, that driver will have to return to the ME again. At the same time, ATA stated its concern that deemphasizing the two-step certification process would result in some individuals with a vision deficiency being wrongly issued medical certification because MEs are not vision specialists, so individuals should see an ophthalmologist or optometrist before the physical qualification examination.
In response to the MRB's recommendation, FMCSA made changes to the terminology in this preamble to emphasize that a vision evaluation must be completed before an individual may be physically qualified under the alternative vision standard (see 49 CFR 391.44(b) and (c)). FMCSA uses “collaborative” to describe the process
For individuals who are aware they will be physically qualified under § 391.44, they begin the certification process by going to an ophthalmologist or optometrist for a vision evaluation. For some, however, the need for a vision evaluation will not be known until they fail to satisfy the existing vision standards at a physical qualification examination. In this situation, a second visit to an ME is unavoidable. Because MEs are not vision specialists, a visit to an ophthalmologist or optometrist is always necessary to ensure the individual's vision is evaluated sufficiently before an ME may issue a medical certificate that ensures the individual can operate a CMV safely. This process is no different from current practice for other conditions when an ME makes a request for a referral to or consultation with another appropriate healthcare provider.
Regardless of how an individual begins the certification process, an individual being evaluated under the alternative vision standard must have an eye evaluation by an ophthalmologist or optometrist to be medically certified. Therefore, there is no concern that deemphasizing the order of the certification process will result in some individuals with a vision deficiency being incorrectly certified as physically qualified. The Vision Evaluation Report, Form MCSA-5871, contains the information necessary for an ME to determine whether the individual satisfies the existing vision standard using more sophisticated testing equipment or requires certification under the alternative vision standard.
FMCSA emphasizes that the ME is to consider the information provided on the Vision Evaluation Report, Form MCSA-5871, but is to use independent medical judgment to evaluate the information and determine whether the individual meets the alternative vision standard. It is the ME who makes the physical qualification determination in the collaborative process.
The same commenter remarked that the proposed process appears to be one that can be subjective, rather than objective like the regulation for individuals with insulin-treated diabetes mellitus that relies on numbers. The commenter noted a driver could simply report that the driver has adjusted to the partial vision loss when that may not be the case. The commenter asked if there could be direct numbers or procedures assigned to the driver's eye evaluation to prevent that from happening. In contrast, one commenter stated no doctor is going to sign off on a driver if the doctor knows a driver cannot drive in a safe manner.
The Vision Evaluation Report, Form MCSA-5871, requests objective information that is the basis for the medical opinions rendered by the ophthalmologist or optometrist. The information is obtained through a vision evaluation that includes formal perimetry results for the field of vision and prior medical documentation. The Agency finds it unlikely an ophthalmologist or optometrist would merely accept an individual's statement that the individual has adapted to and compensated for the vision loss. Instead, the ophthalmologist or optometrist makes that determination based on multiple factors such as the clinical examination, test results, history of the cause and duration of the vision loss, and medical information regarding the time needed to adapt to and compensate for the vision loss based on all the relevant factors. In addition, ophthalmologists and optometrists completing the report must attest that the information provided is true and correct to the best of their knowledge.
The second recommendation was to expand the medical opinion for question 12, regarding sufficient time to adapt and compensate for the change in vision, to require that the individual can drive a CMV safely with the vision condition. The MRB noted that the medical opinion regarding whether the individual has adapted to and compensated for the change in vision sufficiently encompasses depth perception. The MRB further noted that question 12 sufficiently implies that time is needed to adapt and compensate for the change in vision, but appropriately relies on the ophthalmologist or optometrist conducting the vision evaluation to determine the appropriate period of time on a case-by-case basis.
The remainder of the MRB recommendations, three through five, concerned the order of questions and the necessity of certain questions. The MRB recommended the information about stability in questions 11 (vision deficiency) and 13 (progressive eye conditions) be retained because the questions solicit different information. The MRB recommended the Agency change the order of the requested information to be questions 1 through 9, 10, 12, 13, and then 11. This would place the question concerning stability of the vision deficiency (question 11) after the question about progressive eye diseases (question 13). Finally, the MRB recommended the Agency not request information on the report relating to severe non-proliferative diabetic retinopathy and proliferative diabetic retinopathy because they are evaluated separately under the standard for insulin-treated diabetes mellitus.
The final Vision Evaluation Report, Form MCSA-5871, includes the alternative vision standards on page 1 as requested by the MRB. However, FMCSA does not modify the vision standards to reflect a field of vision of at least 120 degrees for the reasons discussed below.
FMCSA agrees with the MRB that reordering the medical opinions and information about progressive eye conditions improves the report. Accordingly, FMCSA inserts the question about progressive eye conditions before the medical opinions. That move consolidates all the vision information before the medical opinions are provided. Question 11, which provides the medical opinion concerning whether the vision deficiency is stable, follows the question about progressive eye conditions as the MRB recommended. FMCSA does not place the medical opinion about stability of the vision deficiency after the other medical opinions, however. The alternative vision standard requires that the vision deficiency must be stable first, and then there must be time to adapt and compensate for the vision change. As recommended, FMCSA expands question 12, regarding adapting to and compensating for the vision deficiency, to include that the individual can drive the CMV safely.
FMCSA agrees with the MRB's recommendation and rationale regarding not to include questions concerning severe non-proliferative and proliferative diabetic retinopathy on the report. These conditions are covered by the separate standard for insulin-treated diabetes mellitus.
The final Vision Evaluation Report, Form MCSA-5871, is available in the docket for this rulemaking. The Agency invites public comment on the report under the Paperwork Reduction Act as provided in the information collection, titled “Medical Qualification Requirements,” discussed in section X.F. below. Comments should be submitted to OIRA at OMB as provided in the
MEs have proven experience making medical certification determinations. This approach of MEs making the physical qualification determination is consistent with Congress' directive in 49 U.S.C. 31149(d) for trained and certified MEs to determine the individual's physical qualification to operate a CMV.
If an ME determines that additional information is necessary to make the certification determination, the ME could confer with the ophthalmologist or the optometrist for more information on the individual's vision medical history and current status, make requests for other appropriate referrals, or request medical records from the individual's treating provider, all with the appropriate consent. MEs routinely confer with and obtain opinions from treating providers concerning the stability of individuals' underlying medical conditions and how the medical conditions may impact safety.
FMCSA continues to conclude, as stated in the NPRM, that even individuals who have a non-functional eye or have lost an eye must undergo vision evaluations at least annually. It is important to monitor compliance with the vision standard in the unaffected eye because of the potential for vision changes in that eye (86 FR 2358). Accordingly, at least annual physical qualification examinations are appropriate for individuals designated as legally blind in one eye. Although Federal vision exemptions are issued for 2 years, individuals undergo a vision evaluation and a physical qualification examination at least annually. The maximum certification period is 12 months for an individual with a vision exemption. Thus, the approach in the alternative vision standard is consistent with the vision exemption program.
If an ME determines an individual merits closer monitoring, the ME may certify the individual for less than the maximum 12-month period. This approach allows the ME to exercise medical discretion as necessary in making individualized medical certification determinations.
The alternative vision standard is not an option for an individual who can meet the existing vision standard with correction. The Vision Evaluation Report, Form MCSA-5871, specifically questions whether the individual has corrected or uncorrected vision, and whether the correction is by glasses or contacts. An ME who receives and reviews a Vision Evaluation Report, Form MCSA-5871, and detects the individual in each eye meets the minimum visual acuity standard of 20/40 with correction, has a field of vision of 70 degrees, and is able to recognize the standard red, green, and amber traffic control signal colors, should inform the individual that medical certification under the alternative vision standard is not applicable.
Under FMCSA's existing vision standard, it is permissible for an individual to have one eye corrected to distant vision and the other corrected for near vision if each eye meets the existing visual acuity standard. If one eye does not meet the visual acuity standard, the individual must obtain and wear corrective lenses that enable the individual to satisfy the visual acuity standard in each eye while operating a CMV.
Concentra and ACOEM commented that the existing vision standard considers 70 degrees in the horizontal meridian in each eye to be sufficient; however, normal field of vision is twice that,
Concentra provided diagrams that it states demonstrate a driver with 70 degrees of horizontal field of vision has a markedly decreased field of vision. Concentra continued that a “field of vision limited to 70 degrees is not normal vision and if detected on an examination, is reason to have a comprehensive evaluation by a specialist.” ACOEM noted the proposed rule would allow a quarter of a normal visual field to meet the standard. Both Concentra and ACOEM commented than any discussion of field of vision should specify if it is from nasal, temporal, or total.
A commenter stated that FMCSA needs to seek comment from eye specialists and professional associations regarding field of vision criteria, which is not supposed to be 70 degrees as stated in the existing vision standard.
In contrast, an ME commenter recommended keeping the 70-degree peripheral vision requirement. A different commenter asked if there have been any studies showing that drivers with a wider field of vision have fewer accidents. The commenter continued “If not, then leave things alone,” especially when there is no evidence that drivers with a narrower field of vision are more dangerous on the road.
Dr. Morris concluded, as has FMCSA, that if an individual meets the proposed vision standard there will be no adverse impact on safety due to the individual's vision. Contrary to ATA's interpretation, Dr. Morris did not support a 120-degree field of vision for the alternative vision standard. Dr. Morris noted only that his patient has field of vision of 120 degrees in the horizontal meridian.
The alternative vision standard adopts the major vision criteria of the current Federal vision exemption program, which were also used in the preceding Federal vision waiver study program since the early 1990s. Under the current vision exemption program, FMCSA considers exemptions for those individuals who have a field of vision of at least 70 degrees in the horizontal meridian in the better eye. An ophthalmologist or optometrist must conduct formal perimetry to assess the field of vision of each eye, including central and peripheral fields, utilizing a testing modality that tests to at least 120 degrees in the horizontal meridian. The ophthalmologist or optometrist must submit the formal perimetry for each eye and interpret the results in degrees of field of vision. The Vision Evaluation Report, Form MCSA-5871, includes the same requirements for testing and formal perimetry. The report also requires a medical opinion from the ophthalmologist or optometrist regarding whether the individual has adapted to and compensated for the change in vision and can drive a CMV safely.
Commenters did not provide in response to the NPRM or NOA any new data that shows drivers with a horizontal field of vision of 70 degrees in the better eye are less safe than drivers with a field of vision of 120 degrees. The Agency has nearly 30 years of experience with drivers who have been physically qualified under the vision waiver study and the exemption programs with a field of vision of at least 70 degrees. Based on that experience, which has not revealed concerns regarding a horizontal field of vision of 70 degrees in the better eye, FMCSA has determined that individuals who meet the alternative vision standard will be at least as safe as the general population of CMV drivers.
However, FMCSA changes the Vision Evaluation Report, Form MCSA-5871, by adding a question after the ophthalmologist or optometrist provides an opinion regarding whether the individual's vision deficiency is stable. It asks, “If yes, when did the vision deficiency become stable?” With respect to progressive eye conditions, FMCSA also adds a request for additional information if the condition is not stable. These changes provide additional information for the ME to independently assess whether the individual's vision is stable.
Determining when vision is stable requires an individualized assessment. Many variables, such as the nature, severity, and duration of the underlying medical condition or vision deficiency, treatment, and response to treatment, influence when an ophthalmologist or optometrist deems vision to be stable for both progressive and fixed vision deficiencies. Therefore, the Agency finds that whether an individual has stable vision is a clinical rather than a regulatory determination and most appropriately defined for the individual by healthcare professionals.
FMCSA does not expect MEs will make unassisted or uninformed vision qualification determinations, as indicated by commenters. The alternative vision standard emphasizes the separate but collaborative roles of ophthalmologists or optometrists and MEs in the medical certification process. Specifically, the ophthalmologist or the optometrist performs a vision evaluation and completes the required Vision Evaluation Report, Form MCSA-5871, based on the clinical findings of the evaluation of the individual and knowledge of the individual's medical history. The report provides the relevant information and medical opinions for the ME to consider when making the final physical qualification determination. The MRB did not state that the medical opinions provided by ophthalmologists and optometrists must be respected. FMCSA emphasizes that the final determination rests with the ME regarding whether the individual meets the alternative vision standard.
OOIDA stated the prolonged period of required intrastate driving can discourage drivers from staying in the industry. OOIDA commented that the alternative vision standard “ensures sufficient physical qualifications are met, but also establishes a more practical process that will help safe drivers continue to operate in the trucking industry.”
A commenter noted that not adopting the alternative vision standard would prolong the process for previously qualified interstate CMV drivers who are no longer able to meet the existing vision standard to return to driving. The commenter also stated the rule would reduce barriers of entry. Another commenter supported the alternative vision standard but emphasized that adequate depth perception is key to avoiding collisions. The commenter continued that under the new standard an individual's depth perception should be assessed first and foremost.
ATA stated it strongly opposed replacing the vision exemption program's criterion of 3 years of driving experience with the road test required in § 391.31. ATA strongly objected to FMCSA's use of vision exemption program data without factoring in the safety implications of removing essential safeguards of the program. ATA also strongly disagreed with FMCSA's assessment that, by eliminating the intrastate CMV experience requirement and replacing it with the mandated road test in § 391.31, the alternative vision standard could increase the number of drivers entering the industry without adversely impacting safety. ATA stated that, regardless of age, years of experience consistently equates to lower rates of crashes, crash involvements, and moving violations, which are factors that were overlooked in the NPRM.
ACOEM commented that the “current requirement for 3 years of commercial driving experience with the vision deficiency would allow the individual with a vision impairment a period of time under which they could adjust to the vision deficit.” ACOEM and Concentra stated that a simple road test is insufficient evaluation for drivers lacking experience operating CMVs. They stated further that the “presently available data regarding the safety of drivers with monocular vision is inconclusive.” They referred to statements in the NPRM that noted crash data on drivers with monocular vision is sparse and conflicting, and cautioned on interpreting data because “monocular vision” is defined differently in the literature. ACOEM and Concentra concluded that these observations “actually support maintaining the requirement for experience over a road test.”
One commenter who is an ME stated FMCSA should retain the 3-year driving experience criterion. Another commenter stated the 3-year driving experience criterion should be kept as a minimum, but that time should be compared with ME reports and driving logs and records for increased safety. A different commenter stated that the 3 years of driving experience does a better job of proving that an individual can safely operate a vehicle than a simple test would.
Another commenter, who noted a modification of the existing standard is needed, stated a one-time test may not be sufficient to balance road safety, but that does not necessarily imply that the current 3-year driving criterion should stay in place. The commenter continued that the alternative vision standard must take into account a reasonable standard time period for individuals to demonstrate their abilities.
ATA, ACOEM, and Concentra commented generally that establishing an alternative vision standard contradicts the MRB's advice, which they stated consistently supported continuing the existing vision standards and current exemption program. It was noted that the MRB raised concerns that data suggest drivers who suffer traumatic eye loss often need time to adjust to their condition and recommended that FMCSA seek comment from eye specialists on the minimum amount of time for individuals to return to CMV driving after a sudden change in binocular vision. The commenters also stated the MRB recommended that FMCSA should investigate whether the 3-year driving experience criterion could be shortened.
ATA stated, while the alternative standard includes a requirement that individuals are not physically qualified to operate a CMV if there has not been sufficient time to allow the individual to adapt to and compensate for the change in vision, the requirement does not entirely address the MRB's recommendation that a period of adjustment is necessary after a sudden loss of vision. ATA stated further that the NPRM fails to sufficiently address why the Agency moved forward with a revision against the MRB's support to maintain the status quo.
With respect to the Vision Evaluation Report, Form MCSA-5871, the MRB noted that “the medical opinion provided by the ophthalmologist or optometrist regarding whether the individual has adapted to and compensated for the change in vision sufficiently encompasses depth perception.” The MRB continued that the requested medical opinion “sufficiently implies that time is needed to adapt and compensate for the change in vision but appropriately relies on the ophthalmologist or optometrist conducting the vision evaluation to determine the appropriate period of time on a case-by-case basis.” The MRB recommended, however, that FMCSA expand the medical opinion “to require that the individual can drive a CMV safely with the vision condition.”
ATA commented that it understands it is difficult to establish a standardized waiting period for adjustment. Nevertheless, ATA expressed concern “that without any guidance, there will be an inconsistency in the certification of a driver depending on the judgement of his or her optometrist, ophthalmologist, or medical examiner.” ATA stated FMCSA “should seek to gather more data and establish clearer guidance on when a medical examiner can assure that a driver has sufficiently adapted to their vision deficiency.”
As stated in the NPRM, and affirmed by Dr. Morris, it is well recognized in the medical literature that individuals with vision loss in one eye can and do develop compensatory viewing behavior to mitigate the vision loss. The 30 years of experience with the vision waiver study and exemption programs has shown that individuals with vision loss in one eye are not limited by their lack of binocularity with respect to driving once they have adapted to and compensated for the change in vision. Dr. Morris has had similar experience with drivers with vision loss in one eye.
The medical literature also shows the time needed to adapt to and compensate for the loss of vision in one eye varies. FMCSA noted in the NPRM that when the criterion was selected in the 1990s the medical community indicated it can take several months to a full year to compensate for a vision impairment (86 FR 2356). FMCSA cited a 2002 study that found the time to adapt to sudden vision loss was 8.8 months and to adapt to gradual vision loss was 3.6 months (86 FR 2357). Thus, the 3 years of intrastate driving experience criterion far exceeds the findings of the medical community that it can take up to a year to adapt to and compensate for vision loss in one eye. In the alternative vision standard, the additional time after a vision deficiency becomes stable provides the period of adjustment needed to adapt to and compensate for the vision loss.
It is no longer necessary to discuss the previous MRB recommendations because it has made new recommendations. In MRB Task 21-1 Report, the MRB accepted moving ahead with the alternative vision standard without the 3 years of driving experience criterion. The MRB agreed with FMCSA's approach of not requiring a minimum period to adapt to and compensate for the loss of vision in one eye. The MRB indicated the time varies by individual and stated it did not have data to establish a specific waiting period. Thus, as the MRB stated, the alternative vision standard “appropriately relies” on the ophthalmologist or optometrist conducting the vision evaluation, which includes a thorough evaluation of depth perception, to determine on a case-by-case basis when an individual has adapted to and compensated for the loss of vision in one eye. It is therefore appropriate that there be inconsistency in the time intervals it takes to adapt to and compensate for the loss of vision in one eye. Because the time needed to adapt to and compensate for a loss of vision is highly dependent on individual factors, gathering more data and attempting to establish clearer guidance is not necessary or feasible.
FMCSA finds a change to the alternative vision standard requirements will help to clarify that there must be a period for the individual to adapt to and compensate for the vision loss after the vision deficiency is deemed stable by a medical professional. Accordingly, FMCSA changes § 391.44(c)(2)(iv) to read, “The individual is not physically qualified to operate a commercial motor vehicle if sufficient time has not passed since the vision deficiency became stable to allow the individual to adapt to and compensate for the change in vision.” FMCSA also makes conforming changes in the Vision Evaluation Report, Form MCSA-5871, to the medical opinion regarding whether the individual has adapted to and compensated for the change in vision.
In response to the AOA comments that it supports the ophthalmologist or optometrist “independently determining” the appropriate period of time needed to adapt and that such a determination “must be respected,” FMCSA clarifies that the MRB noted only that question 12 sufficiently implies that time is needed to adapt to and compensate for the change in vision. FMCSA does not expect the ophthalmologist or optometrist conducting the vision evaluation to independently determine the appropriate period of time to adapt to or compensate for the vision loss or to determine whether an individual meets the relevant standard. Rather, as the MRB indicated, it expects the ME to appropriately rely on all the information provided by the ophthalmologist or optometrist to make the final determination of whether the individual meets the alternative vision standard and should be physically qualified.
FMCSA further revises question 12 to incorporate the MRB's recommendation to expand the medical opinion provided by the ophthalmologist or optometrist to require that the individual can drive a CMV safely with the vision condition. FMCSA also adds a request in the report to provide the month and year the vision deficiency became stable. The additional information could assist MEs to evaluate whether the period over which the individual adapted to and compensated for the change in vision seems reasonable.
The Vision Evaluation Report, Form MCSA-5871, requests the information MEs need to determine whether an individual meets the alternative vision standard. The specific requirements of the alternative vision standard are provided on the report for the informational awareness of ophthalmologists and optometrists conducting the vision evaluations. While there may be multiple ways to evaluate vision, FMCSA expects ophthalmologists and optometrists to provide the information as requested on the report, which requires an evaluation of visual acuity measured in terms of the Snellen chart and field of vision measured in the horizontal meridian, for example.
Comments relating to the safety of drivers in the vision waiver study and
The road test requirement in § 391.31 has been a long-standing provision that was adopted in 1970 to promote CMV safety by ensuring that drivers have demonstrated their skill and knowledge (35 FR 6458, 6459 (Apr. 22, 1970)). This road test requirement (or the equivalent skills test for commercial driver's license (CDL) drivers, see 49 CFR 391.33(a)(1)) is an important aspect of the employer's obligation to ensure that drivers they employ can operate a CMV safely, such as pre-employment record checks (49 CFR 391.23(a) and (d)) and the annual review of a drivers safety performance (49 CFR 391.25).
The employer, rather than the ME, is most familiar with the nature of the operation and the type of equipment the individual will be expected to operate, a particularly important consideration given the substantial variety of commercial vehicles operated in the industry. This circumstance is clearly recognized in the provisions of new § 391.44(d)(1), because it requires the road test to be conducted in accordance with the existing provisions of § 391.31(b) through (g). In particular, the road test regulation states, “The road test must be of sufficient duration to enable the person who gives it to evaluate the skill of the person who takes it at handling the commercial motor vehicle, and associated equipment, that the motor carriers intends to assign to him/her” (49 CFR 391.31(c)). That section goes on to specify the minimum tasks that the employer must include in the road test, all of which are essential aspects for safe operation of the particular CMV to be operated by the individual.
An individual must first be physically qualified by an ME under the alternative vision standard in § 391.44. Then the next step is a road test conducted with both the appropriate vehicle and under the operating conditions the individual has with the vision deficiency. This two-step process ensures that CMV operations can be performed safely. In other words, even if an individual with the vision deficiency is certified as physically qualified by an ME for the first time under the alternative standard, CMV operation will not be permitted by the individual unless and until safe operation can be demonstrated.
ACOEM stated the alternative vision standard shifts responsibility to the employer, who would be responsible for conducting a road test, which could result in inconsistent standards for assessing driver safety. In addition, ACOEM stated there is a concern the number of employer-required road tests will increase significantly. Concentra also commented that the alternative vision standard shifts responsibility to the employer for performing a road test.
In contrast, several commenters supported the inclusion of the road test as part of the alternative vision standard. For example, three commenters stated the road test is an additional safeguard that ensures a driver operating under the alternative vision standard can physically drive the CMV safely and a much more secure driver verification. Another commenter who has held a Federal vision exemption stated that a driving test would tell as much about the ability to drive safely “as a bunch of vision tests.”
FMCSA disagrees that road test examiners lack the skills necessary to evaluate the operation of a CMV by an individual with a vision deficiency. The road test examiners required by § 391.31(b) must be able “to evaluate and determine whether the person who takes the test has demonstrated that he/she is capable of operating the commercial motor vehicle.” Observation by the road test examiner of the specific minimum operational tasks specified in § 391.31(c) (as well as any additional tasks included because of the type of CMV to be operated) does not require any specialized knowledge about the vision deficiency. The road test examiner should observe and evaluate activities involved in operation of a CMV in the same manner for all drivers requiring a road test.
As for ACOEM's concerns about the number of road tests increasing “significantly,” FMCSA does not find this will be the case. Drivers who have an appropriate level of experience operating a CMV with the vision deficiency are excepted from the road test, as provided in new § 391.44(d)(3) through (5). FMCSA uses a high estimate of 868 drivers who would be required to take the road test each year under the new alternative vision standard. The cost for each road test is estimated to be about $50.77, for a total annual cost of $44,000,
Similarly, ATA stated that a road test is an inadequate method to determine if an individual's vision deficiency will impact driving ability. ATA noted the driving environment would vary significantly among carriers and would not be a consistent evaluation tool.
Two commenters were generally supportive of the alternative vision standard as a way of opening the door for more job opportunities. However, one of the commenters stated that a single driving test may be too lenient to evaluate the full scope of driving capabilities. The commenter continued that it might be in the public interest to revise the proposed rule to scrutinize more than the proposed driving test. The other commenter stated that a one-time driving test may not be sufficient because individuals know they are under observation and can perform the one test safely.
Another commenter noted many motor carrier § 391.31 road tests are an exercise in “check the box,” and not a thorough test of the driver's ability. If motor carriers are going to conduct the road tests, the commenter stated clear road-testing standards aimed at determining if the loss of vision is affecting the driver's abilities and pass/fail criteria need to be provided.
FMCSA disagrees with commenters that the road test outlined in § 391.31 is fairly minimal. The regulation requires demonstration of the essential elements of operating a CMV, including driving in traffic, passing other vehicles, turning, braking, backing, and parking. FMCSA acknowledges employers may have somewhat different standards for assessing driver safety; however, § 391.31 ensures all drivers demonstrate
As also noted above, the road test, contrary to commenters' assertions, does require the use of the specific type of vehicle that will be assigned to the individual to operate (see 49 CFR 391.31(c)). In addition, the applicable regulation requires that “The motor carrier shall provide a road test form on which the person who gives the test shall rate the performance of the person who takes it at each operation or activity which is a part of the test” (49 CFR 391.31(d)). If the road test is completed satisfactorily, the road test examiner must sign a certificate that states that it is the examiner's considered opinion that the individual has “sufficient driving skill to operate safely” (49 CFR 391.31(f)). The employer then retains both the road test form and the certificate (or a copy) in the driver qualification file required by 49 CFR 391.51, along with additional documentation that supports a determination that the individual can operate safely.
The road test, when required under the alternative vision standard, is only one of multiple regulatory elements that can work together to ensure that an individual physically qualified under the standard can operate a CMV safely. The alternative vision standard includes the additional safeguards of the collaborative physical qualification process by medical professionals and limiting certification to 12 months. All in all, the road test for individuals qualified under the alternative vision standard is one part of a comprehensive regulatory approach to ensure safe operations of a CMV.
As stated in the NPRM, the 3-year safe driving history criterion of the prior vision waiver study and exemption programs with FMCSA's review of the driving record has served its purpose and is no longer necessary (see 86 FR 2356-57). Finally, the MRB's 2021 recommendations supersede its 2019 recommendations.
One commenter, a motor carrier, stated that the alternative vision standard would be good for the trucking industry and not increase danger to the public. The new standard would open the field to many drivers who do not have or have not been able to get a vision waiver. The commenter noted it would add two drivers with proven work ethic and ability to the company's interstate driving pool right off. Another commenter who is an ME has been unable to certify a few good drivers after they did not pass the vision standard. The commenter noted that it is difficult, particularly for local small businesses, to find qualified CDL operators.
Another commenter stated the proposed regulation has far reaching benefits. It would give individuals with vision that does not meet the existing outdated vision standard the opportunity to drive CMVs. It would boost the CMV driver industry; a boost that is needed now more than ever due to COVID-19. The rule also has the potential to bring greater efficiency to interstate commerce and the country in general. According to the commenter, it stands to reason that if fewer drivers are available it will take longer for goods to travel from place-to-place.
Six commenters who hold intrastate waivers stated they would benefit from being able to operate in interstate commerce. One of these commenters noted missing many good paying loads because of the intrastate restriction and further noted that eliminating it would increase the commenter's income greatly. Seven commenters supported the proposed alternative vision standard because it would either allow them to return to work as a CMV driver following an eye injury or give them the opportunity to become a CMV driver, which they did not have before due to poor vision in one eye.
Several commenters supported the alternative vision standard because the more individualized approach allows capable individuals to demonstrate their ability to operate a CMV safely. For example, the commenters stated the new standard is a step toward less discrimination in the workplace, inclusion of individuals with vision deficiencies, less frequent denial of job opportunities for individuals when a disability does not affect the ability to do the task at hand, and the opportunity for people to change their lives and to live more independently. Several more commenters noted specifically that the alternative vision standard would benefit older workers and especially older drivers with good work ethics and millions of miles worth of experience that benefits the industry and motoring public.
In contrast, one commenter, who has been driving for more than 34 years, stated the vision standard should be left alone. The commenter continued that the proposed alternative vision standard could put a lot of good drivers off the road.
The commenter who stated the alternative vision standard could take good drivers off the road misunderstands this rule. This rule does not change the existing vision standard. FMCSA expects current Federal vision exemption holders, as well as grandfathered drivers, will satisfy the alternative vision standard because it includes requirements they should already meet. Therefore, drivers who are currently operating in interstate commerce should not fail to satisfy the vision physical qualification standards, unless their vision has deteriorated.
This section describes changes relating to the alternative vision standard made in the final rule other than minor and editorial changes. The Agency discusses those changes in the Section-by-Section Analysis below. With respect to the Vision Evaluation Report, Form MCSA-5871, FMCSA describes all changes to the report because it is not discussed in the Section-by-Section Analysis.
FMCSA proposed an alternative vision standard for an individual “who cannot satisfy either the distant visual acuity or field of vision standard, or both,” in the existing vision standard in one eye. ACOEM commented the proposed vision standard seems to allow any driver to meet the vision standard if one eye is at least 20/40 with or without corrective lenses. ACOEM continued that this would permit a driver who chooses not to obtain corrective lenses to use the proposed standard if the driver's vision in the better eye meets the existing vision standard. Concentra provided a similar comment. As discussed above, it was not the Agency's intent to change the scope of the current vision exemption program in this regard or to allow individuals who simply need corrective lenses to be physically qualified under the alternative vision standard.
FMCSA clarifies in the final rule that the alternative vision standard is applicable only if the worse eye does not meet the distant visual acuity standard with corrective lenses. FMCSA adds the limitation in § 391.41(b)(10)(ii) that a person who meets the requirements in § 391.44 is physically qualified to operate a CMV “if the person does not satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or the field of vision standard, or both, in paragraph (b)(10)(i) of this section.” The Agency makes conforming changes in the title of § 391.44, in paragraphs (a) and (c) of § 391.44, and in new § 391.45(f).
In paragraph (c) of § 391.44, FMCSA proposed, “At least annually, but no later than 45 days after an ophthalmologist or optometrist signs and dates the Vision Evaluation Report, Form MCSA-5871, an individual who cannot satisfy either the distant visual acuity or field of vision standard, or both, in § 391.41(b)(10)(i) in one eye must be medically examined and certified by a medical examiner as physically qualified to operate a commercial motor vehicle in accordance with § 391.43.” The sentence is long and not easy to follow. To improve readability, FMCSA removes the clause “but no later than 45 days after an ophthalmologist or optometrist signs and dates the Vision Evaluation Report, Form MCSA-5871,” and includes the substance in a new second sentence. To provide additional clarity, the Agency changes “no later than” to “not more than” 45 days. The second sentence reads, “The examination must begin not more than 45 days after an ophthalmologist or optometrist signs and dates the Vision Evaluation Report, Form MCSA-5871.”
FMCSA proposed in § 391.44(c)(2)(iv) that an individual is not physically qualified to operate a CMV “if there has not been sufficient time to allow the individual to adapt to and compensate for the change in vision.” FMCSA has determined a change to this requirement will help to clarify that there must a period for the individual to adapt to and compensate for the vision loss after the vision deficiency is deemed stable by a medical professional. Accordingly, FMCSA removes “there has not been sufficient time” and inserts “sufficient time has not passed since the vision deficiency became stable.” Section 391.44(c)(2)(iv) reads, “The individual is not physically qualified to operate a commercial motor vehicle if sufficient time has not passed since the vision deficiency became stable to allow the individual to adapt to and compensate for the change in vision.”
For the final Vision Evaluation Report, Form MCSA-5871, FMCSA makes several editorial changes on page 1. The paragraph reminding that the report contains sensitive information moves to the footer and appears on every page. FMCSA changes the heading “Instructions to the Individual” to “Information for the Individual” and places the paragraph before the new heading “Information for the Ophthalmologist or Optometrist.” The style for the definition of monocular vision changes from a paragraph to a numerical list for consistency purposes. Other minor editorial and formatting changes are made throughout the report for clarity, consistency, or as a result of making the report a fillable document.
The Agency deletes “(if applicable)” after the request for a driver's license number because it is not necessary. All individuals obtaining a vision evaluation will have some type of driver's license.
In the “Information for the Individual” section, FMCSA changes “no later than” to “not more than” 45 calendar days to conform the report to the revised regulatory text. FMCSA deletes “certified” before “medical examiner” in this section, as well as in the “Information for the Ophthalmologist or Optometrist” section, because it is no longer necessary. All MEs have been required to be certified and listed on FMCSA's National Registry of Certified Medical Examiners for several years.
In the first paragraph under the new heading “Information for the Ophthalmologist or Optometrist,” FMCSA adds in the first sentence that the individual is being evaluated “as part of the process” to determine whether the individual meets FMCSA's vision standard. This change clarifies that the physical qualification of individuals to operate a CMV is a
In paragraph (2) of FMCSA's definition of
As the MRB recommended, FMCSA adds the alternative vision standard that individuals with monocular vision, as defined by FMCSA, must satisfy to be physically qualified. The Agency states that the standard is provided “For general informational purposes only” to ensure that ophthalmologists and optometrists understand that they do not determine whether the individual meets the alternative vision standard for medical certification to operate a CMV.
In question 3 on page 2 pertaining to distant visual acuity, FMCSA replaces “(please provide both if applicable)” with “(select N/A if there is no vision in an eye).” The Agency adds boxes that can be checked to indicate distant visual acuity is not applicable when there is no vision in an eye.
With respect to question 7 on page 2, which asks if the individual has monocular vision as defined by FMCSA, the Agency includes a follow-up request. It provides, “If yes, cause of the monocular vision (describe),” which was question 8 in the draft report. FMCSA makes this change for consistency with the style for other follow-up questions in the report. FMCSA renumbers the following questions accordingly.
In question 8, “When did the monocular vision begin?” changes to “Date the monocular vision began:” for consistency with the style of other entries.
Question 10 relating to progressive eye conditions, which was question 13 in the draft report, follows the questions regarding monocular vision to consolidate the medical information on the report. All the medical opinions follow. Instead of providing information about progressive eye conditions in a table, the report now uses a narrative format. FMCSA adds a request for additional information if the condition is not stable.
As recommended by the MRB, the medical opinion regarding whether the vision deficiency is stable follows the information about progressive eye conditions as question 11. FMCSA adds a follow-up request in question 11 for the date the vision deficiency became stable if it is deemed stable. This change provides additional information for the ME regarding how long the vision deficiency has been stable. In question 12, the Agency conforms the language to the revised regulatory text and expands the medical opinion as recommended by the MRB. It reads, “In your medical opinion, has sufficient time passed since the vision deficiency became stable to allow the individual to adapt to and compensate for the change in vision and to drive a commercial motor vehicle safely?”
FMCSA numbers the medical opinion asking if a vision evaluation is required more often than annually as question 13. FMCSA includes in the follow-up request not only how often a vision evaluation should be required, but why. FMCSA adds space to enter additional comments and instructions to attach additional pages as needed as a new question 14. Finally, FMCSA makes minor style changes to conform punctuation and formatting throughout the report.
The final Vision Evaluation Report, Form MCSA-5871, is available in the docket for this rulemaking. The Agency invites public comment on the report under the Paperwork Reduction Act as provided in the information collection, titled “Medical Qualification Requirements,” discussed in section X.F. below. Comments should be submitted to OIRA at OMB as provided in the
Motor carriers and drivers are subject to the laws and regulations of the countries in which they operate unless an international agreement states otherwise. Drivers and carriers should be aware of the regulatory differences among nations. Pursuant to the terms of the 1998 medical reciprocity agreement with Canada, the United States will notify Canada that it has adopted an alternative vision standard and propose the countries review their applicable vision standards to determine whether they remain equivalent.
This section-by-section analysis provides changes from the proposed rule. FMCSA discusses regulatory changes first in numerical order, followed by changes to Agency guidance.
FMCSA adopts § 391.31(f) as proposed and removes the driver's social security number, the driver's license number, and the State of issuance of the driver's license from the Certification of Road Test. The Agency adopts paragraph (h) as proposed but adds the control number (2126-0072) provided by OMB for the information collection.
FMCSA adopts § 391.41(b)(10) as proposed but adds a limitation to clarify when the alternative vision standard is applicable. Specifically, the Agency adds the limitation in § 391.41(b)(10)(ii) that a person is physically qualified to operate a CMV who meets the requirements in § 391.44, “if the person does not satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or the field of vision standard, or both, in paragraph (b)(10)(i) of this section.”
FMCSA adds in § 391.43(b)(1) that an ophthalmologist may perform the vision part of the physical qualification examination as proposed. FMCSA also inserts the word “licensed” before optometrist to conform with the existing regulation.
FMCSA changes the title of § 391.44 and introductory paragraphs (a) and (c) to conform to the change in § 391.41(b)(10)(ii). Specifically, FMCSA clarifies the alternative vision standard is applicable to an individual “who does not satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or the field of vision standard, or both,” in renumbered § 391.41(b)(10)(i).
In introductory paragraph (b), the Agency inserts the word “licensed” before optometrist for consistency and clarity. In paragraph (b)(2), FMCSA replaces “his or her” with “the ophthalmologist or optometrist's.”
To improve readability in introductory paragraph (c), FMCSA removes the clause “but no later than 45 days after an ophthalmologist or optometrist signs and dates the Vision Evaluation Report, Form MCSA-5871,” and includes the substance in a new second sentence. To provide additional clarity, the Agency changes “no later than” to “not more than” 45 days. The second sentence reads, “The examination must begin not more than 45 days after an ophthalmologist or optometrist signs and dates the Vision Evaluation Report, Form MCSA-5871.”
FMCSA makes clarifying changes to paragraph (c)(2)(iv). FMCSA removes “there has not been sufficient time” and inserts “sufficient time has not passed since the vision deficiency became stable.” The paragraph reads, “The individual is not physically qualified to operate a commercial motor vehicle if sufficient time has not passed since the vision deficiency became stable to allow the individual to adapt to and compensate for the change in vision.”
FMCSA makes minor changes in paragraph (d). In paragraph (d)(3)(ii)(A), FMCSA inserts “in the specific” before excepted interstate commerce to remind the reader that only interstate commerce excepted by either § 390.3T(f) or § 391.2 satisfies the requirements of the regulation. FMCSA changes a citation in paragraph (d)(4) from “§ 391.41(b)(10)” to “§ 391.41(b)(10)(i)” to clarify that the existing vision standard is being referenced. In addition, the Agency makes a tense change from “holds” to “held.” FMCSA also makes a tense change in paragraph (d)(5) from “is” to “was.”
FMCSA makes conforming changes to § 391.45(f). It provides, in relevant part, any driver “who does not satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or the field of vision standard, or both, in § 391.41(b)(10)(i)” must be recertified at least every 12 months.
FMCSA adopts § 391.51(b)(3) as proposed, which provides the driver qualification file must include the written statement from the motor carrier and certification from the driver required by § 391.44(d)(3).
FMCSA proposed to change the title of § 391.64 to remove a reference to a prior diabetes waiver study program; however, that change was made in a different rule (86 FR 35637 (July 7, 2021)). Otherwise, FMCSA adopts § 391.64 as proposed. This section provides that this rule does not apply to individuals certified under § 391.64(b) for 1 year from the effective date of this rule. After 1 year, any MEC, Form MCSA-5876, issued under § 391.64(b) will be void.
This rule amends a regulation that has associated guidance. Such guidance does not have the force and effect of law, is strictly advisory, and is not meant to bind the public in any way. Conformity with guidance is voluntary. Guidance is intended only to provide information to the public regarding existing requirements under the law or FMCSA policies. Guidance does not alter the substance of a regulation.
FMCSA removes section II.J., Vision: § 391.41(b)(10), in the Medical Advisory Criteria of appendix A to part 391 in its entirety as proposed.
Guidance for specific regulations is available through the Guidance Portal on FMCSA's website. The Agency revises the guidance to Question 3 for § 391.41
The qualification standards cover 13 areas, which directly relate to the driving function. All but two of the standards require a judgment by the medical examiner. A person's qualification to drive is determined by a medical examiner who is knowledgeable about the driver's functions and whether the driver's physical condition is adequate to enable the driver to operate the vehicle safely. In the case of hearing and epilepsy, the current standards are absolute, providing no discretion to the medical examiner. However, drivers who do not meet the current requirements may apply for an exemption as provided by 49 CFR part 381.
FMCSA has considered the impact of this final rule under E.O. 12866 (58 FR 51735 (Oct. 4, 1993)), Regulatory Planning and Review; E.O. 13563 (76 FR 3821 (Jan. 21, 2011)), Improving Regulation and Regulatory Review; and DOT's regulatory policies and procedures. OIRA within OMB has determined that this final rule is not a significant regulatory action under section 3(f) of E.O. 12866, as supplemented by E.O. 13563, and does not require an assessment of potential costs and benefits under section 6(a)(3) of E.O. 12866. Accordingly, OMB has not reviewed it under that E.O. The Agency has determined that the final rule results in cost savings.
The Regulatory Impact Assessment follows:
Drivers who do not satisfy, with the worse eye, either the existing distant visual acuity standard with corrective lenses or the field of vision standard, or both, may apply to FMCSA for an
If an exemption is granted, the driver must meet certain conditions to maintain the exemption. The driver must receive an annual vision evaluation by an ophthalmologist or optometrist and an annual physical qualification examination by an ME. In addition, the Agency must monitor the implementation of each exemption and immediately revoke an exemption if: The driver fails to comply with the terms and conditions; the exemption has resulted in a lower level of safety than was maintained before the exemption; or continuation of the exemption would not be consistent with the goals and objectives of the Federal Motor Carrier Safety Regulations (49 CFR 381.330).
FMCSA monitors vision-exempted drivers on a quarterly basis. If any potentially disqualifying information is identified, FMCSA will request a copy of the violation or crash report from the driver. Should the violation be disqualifying, FMCSA will revoke the exemption immediately.
Currently, 1,967 drivers hold vision exemptions.
As a result of this final rule, an individual who does not satisfy, in the worse eye, either the existing distant visual acuity standard with corrective lenses or field of vision standard, or both, can be physically qualified without applying for or receiving an exemption. The individual will still have to receive a vision evaluation by an ophthalmologist or optometrist. The ophthalmologist or optometrist will complete the Vision Evaluation Report, Form MCSA-5871.
For those who obtain an MEC, Form MCSA-5876, this action may represent a streamlined process compared to the requirements of the vision exemption program in that the driver will not need to compile and submit the letter of application and supporting documentation to FMCSA, or respond to any subsequent requests for information. However, it is possible that the ME could issue a certificate that is valid for a shorter time to monitor the condition. In such circumstances, under the vision exemption program, the applicant would likely not receive an exemption. For those who do not obtain an MEC, Form MCSA-5876, the result may or may not have been the same under the vision exemption program.
This final rule will result in the discontinuation of the Federal vision exemption program. Instead, the physical qualification determination of individuals in, or who would be applying to, the exemption program will be made by an ME, who is trained and qualified to make such determinations, considering the information received in the Vision Evaluation Report, Form MCSA-5871, from the ophthalmologist or optometrist.
Instead of requiring 3 years of intrastate driving experience with the vision deficiency as in the current exemption program, individuals physically qualified under the alternative vision standard for the first time must complete a road test before operating in interstate commerce. The road test will be conducted by motor carriers in accordance with the road test already required by § 391.31.
As described in the NPRM, individuals will be excepted from the road test requirement if they have 3 years of intrastate or specific excepted interstate CMV driving experience with the vision deficiency, hold a valid Federal vision exemption, or are medically certified under § 391.64(b). These individuals have already demonstrated they can operate a CMV safely with the vision deficiency. FMCSA finds that a road test is an appropriate indicator of an individual's ability to operate a CMV safely with the vision deficiency. Thus, the Agency expects there will be no adverse impact on safety from eliminating the intrastate driving experience criterion. When the Federal Highway Administration (FHWA), the predecessor agency to FMCSA, adopted the road test in § 391.31, it stated that the interests of CMV safety would be promoted by ensuring drivers have demonstrated their skill by completing the road test (35 FR 6458, 6450 (Apr. 22, 1970)).
The intrastate driving experience criterion has the limitation that some States do not have waiver programs through which drivers can obtain the driving experience necessary to meet the criteria of the Federal vision exemption program. The removal of the 3-year experience criterion under this final rule will more readily allow these individuals to operate in interstate commerce. However, the current number of exemption holders, grandfathered drivers, and applicants denied exemptions annually represents less than 1 percent of all interstate CMV drivers.
The Agency expects this final rule will be safety neutral. FMCSA notes that, although it will no longer directly monitor the safety performance of drivers, motor carriers will continue to monitor individuals' safety performance when hiring drivers and during the annual inquiry and review of the driving record required by §§ 391.23 and 391.25, respectively.
FMCSA estimates that the final rule will result in incremental cost savings of approximately $1.6 million annually from the elimination of the Federal vision exemption program and contract expenditures (Table 1). As described in detail below, FMCSA also accounts for
The 1,967 current vision exemption holders will no longer have to apply for exemptions and potential drivers who would not qualify for an exemption because they do not have 3 years of intrastate driving experience may meet the alternative vision standard and be able to operate a CMV in interstate commerce. This rule leads to a reduction in burden, as drivers will no longer be required to create and assemble the substantial amount of information and documentation necessary to apply for or renew an exemption, or to respond to subsequent requests for information. However, the affected population is small (less than 1 percent of CMV drivers), and the relative advantages for these individuals are unlikely to affect market conditions in the truck and bus industries.
FMCSA estimates that the road test will result in a total annual cost impact of $44,000 (Table 2). There will be approximately 868 drivers requiring a road test under § 391.44 each year. This number is the average of new applications for the vision exemption program FMCSA received over years 2018 through 2020.
As described above, motor carriers will be responsible for administering the test to the drivers, which is estimated to take 0.55 hours (33 minutes). For the hourly wage rates, FMCSA used $31 for the drivers
Although the Agency acknowledges there are motor carriers employing multiple drivers who would be certified under the new alternative vision standard, FMCSA lacks data to estimate the exact number of motor carriers impacted by this rule. Therefore, to ensure the inclusion of all affected motor carriers, FMCSA opted for a conservative approach of assuming a 1:1 ratio of drivers per motor carrier, making $44,000 a likely overestimate. Additionally, there may be some drivers medically certified under the new alternative vision standard who are also motor carriers, in which case the test must be given by a person other than themselves (49 CFR 391.31(b)). FMCSA treats the impacts on these drivers as equivalent to those of all affected drivers. Using this approach, the Agency estimates the cost for each road test at $50.77.
Eliminating the prohibition on certifying individuals who do not satisfy, in the worse eye, either the existing visual acuity standard with corrective lenses or field of vision standard, or both, without an exemption will enable more qualified individuals to operate as interstate CMV drivers without compromising safety. These drivers are relieved of the time and paperwork burden associated with applying for or renewing an exemption.
Regarding risk, the Agency expects no changes in risk resulting from the very small number of additional individuals affected by this final rule relative to those of the baseline. Therefore, FMCSA considers this final rule to be safety neutral.
This final rule is not a
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This rule affects drivers and motor carriers. Drivers are not considered small entities because they do not meet the definition of a small entity in section 601 of the RFA. Specifically, drivers are considered neither a small business under section 601(3) of the RFA, nor are they considered a small organization under section 601(4) of the RFA.
The Small Business Administration (SBA) defines the size standards used to classify entities as small. SBA establishes separate standards for each industry, as defined by the NAICS. This rule will affect many different industry sectors in addition to the Transportation and Warehousing sector (NAICS sectors 48 and 49); for example, the Construction sector (NAICS sector 23), the Manufacturing sector (NAICS sectors 31, 32, and 33), and the Retail Trade sector (NAICS sectors 44 and 45). Industry groups within these sectors have size standards for qualifying as small based on the number of employees (
The RFA does not define a threshold for determining whether a specific regulation results in a significant impact. However, the SBA, in guidance to government agencies, provides some objective measures of significance that the agencies can consider using. One measure that could be used to illustrate a significant impact is revenue costs,
Consequently, I certify that this action will not have a significant economic impact on a substantial number of small entities.
In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996,
Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the SBA's Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or Tribal government, in the aggregate, or by the private sector of $170 million (which is the value equivalent of $100 million in 1995, adjusted for inflation to 2020 levels) or more in any 1 year. Although this final rule will not result in such an expenditure, the Agency discusses the effects of this rule elsewhere in this preamble.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) requires that an agency consider the impact of paperwork and other information collection burdens imposed on the public. An agency is prohibited from collecting or sponsoring an information collection, as well as imposing an information collection requirement, unless it displays a valid OMB control number (5 CFR 1320.8(b)(3)(vi)).
This final rule impacts an existing information collection request (ICR) titled “Medical Qualification Requirements” (OMB control number 2126-0006), and a new ICR titled “391.31 Road Test Requirement” (OMB control number 2126-0072). The ICRs will be discussed separately below, followed by a discussion of the net information collection and reporting burdens of the final rule. FMCSA will submit a copy of the final rule to OIRA at OMB for review and approval of the information collections.
This final rule revises the existing approved Medical Qualification Requirements ICR (OMB control number 2126-0006), which expires on December 31, 2024. FMCSA seeks approval for the revision of the ICR due to the Agency's development of this rule, which includes the use of the Vision Evaluation Report, Form MCSA-5871.
The alternative vision standard eliminates the need for the Federal vision exemption program and the related information collection (IC-3a). The vision exemption program requires individuals to submit personal, health, and driving information during the application process. In addition, motor carriers must copy and file the vision exemption in the driver qualification file. FMCSA attributes, in the OMB-approved supporting statement for IC-3a, 2,236 annual burden hours at a cost of $67,486 to obtain and maintain a vision exemption, which is eliminated by this rule.
The net effect of this rule on this ICR is a reduction in burden hours of 1,617 hours (619 hours related to the Vision Evaluation Report, Form MCSA-5871 −2,236 hours related to the current vision exemption program = −1,617). In addition, the net effect of the rule with respect to costs is a reduction of $15,356 ($52,130 related to the report −$67,486 related to the current vision exemption program = −$15,356).
The revised total annual estimated burden associated with the Medical Qualification Requirements ICR that reflects the addition of the information collection for the Vision Evaluation Report, Form MCSA-5871, and elimination of the Federal vision exemption program is as follows.
Additional information for the assumptions, calculations, and methodology summarized above is provided in the supporting statement for the Medical Qualification Requirements ICR. The supporting statement is available in the docket for this rulemaking.
FMCSA establishes a new 391.31 Road Test Requirement ICR. The ICR estimates the paperwork burden motor carriers incur to comply with the reporting and recordkeeping tasks required for the road test associated with 49 CFR 391.31. FMCSA has not previously accounted for the burden associated with § 391.31 road tests; accordingly, the ICR accounts for the burden. The ICR includes the incremental burden for motor carriers associated with § 391.31 road tests due to this final rule.
Sections 391.31 and 391.51 are based on the authority of the Motor Carrier Act of 1935
Motor carriers must ensure each driver has the skill to operate a CMV safely. The information collected and maintained by motor carriers in each driver qualification file related to the road test substantiates the driver can operate a CMV safely and the motor carrier has fulfilled its regulatory requirements. It also aids Federal and State safety investigators in assessing the qualifications of drivers.
Public interest in highway safety dictates that employers hire drivers who can safely operate CMVs amid the various physical and mental demands of truck and bus driving. Section 391.31 requires a motor carrier to conduct a road test when the motor carrier hires a new driver. The motor carrier is required to rate the performance of the driver during the test on a road test form. If the road test is successfully completed, the motor carrier completes a certificate of driver's road test and provides a copy to the driver. Motor carriers may maintain the required road test form and certificate electronically or via paper copy. The motor carrier must retain the signed road test form and the signed certificate in the driver qualification file. Generally, driver qualification files must be maintained at the motor carrier's principal place of business. Neither the road test form nor the certificate is routinely submitted to FMCSA. A motor carrier would only make the information available when requested by an FMCSA or State safety investigator for an investigation or audit.
As indicated above, there are three reporting and recordkeeping tasks motor carriers perform regarding the road test required by § 391.31 when they hire a new driver. The three tasks are:
1. The motor carrier completes and signs the road test form while the driver performs a pre-trip inspection and the driving portion of the road test (49 CFR 391.31(d)).
2. If the driver successfully passes the road test, the motor carrier completes a certificate of driver's road test in substantially the form prescribed in § 391.31(f) (49 CFR 391.31(e)) and gives the driver a copy (49 CFR 391.31(g)).
3. The motor carrier retains in the driver qualification file the original signed road test form and the original, or a copy, of the signed certificate of driver's road test (49 CFR 391.31(g)(1) and (2)).
To estimate costs, FMCSA assumes a compliance officer will be the person who will complete the road test form and associated certificate, and a file clerk will be the person who will store the documents. The median salary for a compliance officer is $61.35 per hour. The median salary for a file clerk is $29.42 per hour.
The ICR estimates the information-collection burden incurred by motor carriers associated with the § 391.31 road test in two circumstances. The first is when the road test is required by § 391.31 (IC-1); the second is when the road test is required as part of the alternative vision standard in § 391.44 (IC-2). Most of the motor carrier burden hours and cost for the information collection relates to IC-1 and is reflected below in the total burden and cost amounts for the ICR.
IC-2 consists of the incremental burden associated with the requirement in this rule that individuals physically qualified under the alternative vision standard in § 391.44 for the first time must complete a road test in accordance with § 391.31. However, individuals are excepted from the road test requirement if they have 3 years of intrastate or specific excepted interstate CMV driving experience with the vision deficiency, hold a valid Federal vision exemption, or are medically certified under § 391.64(b). FMCSA estimates there will be approximately 868 drivers requiring a road test under § 391.44 each year. Therefore, the respondent universe of motor carriers is also 868.
The estimated incremental annual burden associated with the requirement in this rule that certain individuals physically qualified under § 391.44 for the first time must complete a road test in accordance with § 391.31 (IC-2), is as follows.
The total estimated annual burden associated with the 391.31 Road Test Requirement ICR for IC-1 and IC-2 is as follows:
Additional information for the assumptions, calculations, and methodology summarized above is provided in the supporting statement for the 391.31 Road Test Requirement ICR. The supporting statement is available in the docket for this rulemaking.
As shown in Table 4 below, the combined net effect of the rule on the two ICRs is a reduction in burden hours of 1,140 and an addition of cost in the amount of $12,255.
FMCSA asks for comment on the information collection requirements of this rule, as well as the revised total estimated burden associated with the Medical Qualification Requirements ICR and the total estimated burden associated with the new 391.31 Road Test Requirement ICR. Specifically, the Agency asks for comment on: (1) Whether the proposed information collections are necessary for FMCSA to perform its functions; (2) how the Agency can improve the quality, usefulness, and clarity of the information to be collected; (3) the accuracy of FMCSA's estimate of the burden of this information collection; and (4) how the Agency can minimize the burden of the information collection.
If you have comments on the collection of information, you must submit those comments as outlined under
A rule has implications for federalism under section 1(a) of E.O. 13132 if it has “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” FMCSA has determined that this rule does not have substantial direct costs on or for States, nor will it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Impact Statement.
Section 522 of title I of division H of the Consolidated Appropriations Act, 2005,
This rule requires the collection of personally identifiable information and protected health information via the Vision Evaluation Report, Form MCSA-5871. The privacy risks and effects associated with this rule are not unique and have been addressed previously by the DOT/FMCSA 009—National Registry of Certified Medical Examiners system of records notice published on October 4, 2019 (84 FR 53211).
Before an individual may be medically certified under the alternative vision standard adopted in this rule, the individual must have a vision evaluation conducted by an ophthalmologist or optometrist. The ophthalmologist or optometrist records the findings of the vision evaluation and provides specific medical opinions on
The Vision Evaluation Report, Form MCSA-5871, provides a means for healthcare professionals to exchange information about an individual for purposes of regulatorily required medical certification to operate a CMV. The report promotes uniform and consistent communication between ophthalmologists or optometrists and the certifying MEs. This is the same type of communication that occurs when the ME needs to follow up with an individual's primary care provider regarding the individual's health and exchanges information. Therefore, no new category of medical or privacy information is generated because of this rule.
The Agency expects that the Vision Evaluation Report, Form MCSA-5871, will be safeguarded along with all the other medical information that these healthcare providers retain. The report must be treated and retained as part of the Medical Examination Report Form, MCSA-5875, in the ME's medical records for the individual. The report must be retained by the ME for at least 3 years from the date of the physical qualification examination. The Vision Evaluation Report, Form MCSA-5871, is provided to FMCSA only upon request if there is an investigation or audit. Therefore, this rule provides a privacy-positive outcome because it results in less sensitive data being held by the Agency. There is privacy risk not controlled by the Agency because the Vision Evaluation Report, Form MCSA-5871, is retained by MEs. However, as healthcare providers, MEs are required to retain and disclose medical information and personally identifiable information in accordance with applicable Federal and State privacy laws.
With respect to the requirement that a Vision Evaluation Report, Form MCSA-5871, must be completed as part of the new alternative vision standard, the Agency has completed a Privacy Threshold Assessment to evaluate the risks and effects the requirement has on collecting, storing, and sharing personally identifiable information and protected health information.
With respect to the requirement for a road test as part of the alternative vision standard, the Agency also has completed a Privacy Threshold Assessment to evaluate the risks and effects the requirement has on collecting, storing, and sharing personally identifiable information.
This rule does not have Tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
FMCSA analyzed this final rule pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor carriers, Reporting and recordkeeping requirements, Safety, Transportation.
Accordingly, FMCSA amends 49 CFR part 391 as follows:
49 U.S.C. 504, 508, 31133, 31136, 31149, 31502; sec. 4007(b), Pub. L. 102-240, 105 Stat. 1914, 2152; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677; sec. 215, Pub. L. 106-159, 113 Stat. 1748, 1767; sec. 32934, Pub. L. 112-141, 126 Stat. 405, 830; secs. 5403 and 5524, Pub. L. 114-94, 129 Stat. 1312, 1548, 1560; sec. 2, Pub. L. 115-105, 131 Stat. 2263; and 49 CFR 1.87.
The addition reads as follows:
(h) The information collection requirements of this section have been reviewed by the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(b) * * *
(10)(i) Has distant visual acuity of at least 20/40 (Snellen) in each eye without corrective lenses or visual acuity separately corrected to 20/40 (Snellen) or better with corrective lenses, distant binocular acuity of at least 20/40 (Snellen) in both eyes with or without corrective lenses, field of vision of at least 70° in the horizontal meridian in each eye, and the ability to recognize the colors of traffic signals and devices showing standard red, green, and amber; or
(ii) Meets the requirements in § 391.44, if the person does not satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or the field of vision standard, or both, in paragraph (b)(10)(i) of this section;
(b) * * *
(1) A licensed ophthalmologist or licensed optometrist may perform the part of the medical examination that involves visual acuity, field of vision, and the ability to recognize colors as specified in § 391.41(b)(10).
(a)
(1) The individual meets the other physical qualification standards in § 391.41 or has an exemption or skill performance evaluation certificate, if required; and
(2) The individual has the vision evaluation required by paragraph (b) of this section and the medical examination required by paragraph (c) of this section.
(b)
(1) During the evaluation of the individual, the ophthalmologist or optometrist must complete the Vision Evaluation Report, Form MCSA-5871.
(2) Upon completion of the Vision Evaluation Report, Form MCSA-5871, the ophthalmologist or optometrist must sign and date the Report and provide the ophthalmologist or optometrist's full name, office address, and telephone number on the Report.
(c)
(1) The medical examiner must receive a completed Vision Evaluation Report, Form MCSA-5871, signed and dated by an ophthalmologist or optometrist for each required examination. This Report shall be treated and retained as part of the Medical Examination Report Form, MCSA-5875.
(2) The medical examiner must determine whether the individual meets the physical qualification standards in § 391.41 to operate a commercial motor vehicle. In making that determination, the medical examiner must consider the information in the Vision Evaluation Report, Form MCSA-5871, signed by an ophthalmologist or optometrist and, utilizing independent medical judgment, apply the following standards in determining whether the individual may be certified as physically qualified to operate a commercial motor vehicle.
(i) The individual is not physically qualified to operate a commercial motor vehicle if, in the better eye, the distant visual acuity is not at least 20/40 (Snellen), with or without corrective lenses, and the field of vision is not at least 70° in the horizontal meridian.
(ii) The individual is not physically qualified to operate a commercial motor vehicle if the individual is not able to recognize the colors of traffic signals and devices showing standard red, green, and amber.
(iii) The individual is not physically qualified to operate a commercial motor vehicle if the individual's vision deficiency is not stable.
(iv) The individual is not physically qualified to operate a commercial motor vehicle if sufficient time has not passed since the vision deficiency became stable to allow the individual to adapt to and compensate for the change in vision.
(d)
(2) For road tests required by paragraph (d)(1) of this section, the provisions of § 391.33 for the equivalent of a road test do not apply. If an individual required to have a road test by paragraph (d)(1) of this section successfully completes the road test and is issued a certificate of driver's road test in accordance with § 391.31, then any otherwise applicable provisions of § 391.33 will apply thereafter to such individual.
(3) An individual physically qualified under this section for the first time is not required to complete a road test in accordance with § 391.31 if the motor carrier responsible for completing the road test under § 391.31(b) determines the individual possessed a valid commercial driver's license or non-commercial driver's license to operate, and did operate, a commercial motor vehicle in either intrastate commerce or in interstate commerce excepted by § 390.3T(f) of this subchapter or § 391.2 from the requirements of this subpart with the vision deficiency for the 3-year period immediately preceding the date of physical qualification under this section for the first time.
(i) The individual must certify in writing to the motor carrier the date the vision deficiency began.
(ii) If the motor carrier determines the individual possessed a valid commercial driver's license or non-commercial driver's license to operate, and did operate, a commercial motor vehicle in either intrastate commerce or in interstate commerce excepted by either § 390.3T(f) of this subchapter or § 391.2 from the requirements of this subpart with the vision deficiency for the 3-year period immediately preceding the date of physical qualification in accordance with this section for the first time, the motor carrier must—
(A) Prepare a written statement to the effect that the motor carrier determined the individual possessed a valid license and operated a commercial motor vehicle in intrastate or in the specific excepted interstate commerce (as applicable) with the vision deficiency for the 3-year period immediately preceding the date of physical qualification in accordance with this section for the first time and, therefore, is not required by paragraph (d) of this section to complete a road test;
(B) Give the individual a copy of the written statement; and
(C) Retain in the individual's driver qualification file the original of the written statement and the original, or a copy, of the individual's certification regarding the date the vision deficiency began.
(4) An individual physically qualified under this section for the first time is not required to complete a road test in accordance with § 391.31 if the individual held on March 22, 2022, a valid exemption from the vision standard in § 391.41(b)(10)(i) issued by FMCSA under 49 CFR part 381. Such an individual is not required to inform the motor carrier that the individual is excepted from the requirement in paragraph (d)(1) of this section to have a road test.
(5) An individual physically qualified under this section for the first time is
The revision and addition read as follows:
(b) Any driver who has not been medically examined and certified as qualified to operate a commercial motor vehicle during the preceding 24 months, unless the driver is required to be examined and certified in accordance with paragraph (c), (d), (e), (f), (g), or (h) of this section;
(f) Any driver who does not satisfy, with the worse eye, either the distant visual acuity standard with corrective lenses or the field of vision standard, or both, in § 391.41(b)(10)(i) and who has obtained a medical examiner's certificate under the standards in § 391.44, if such driver's most recent medical examination and certification as qualified to drive did not occur during the preceding 12 months;
(b) * * *
(3) The certificate of driver's road test issued to the driver pursuant to § 391.31(e), a copy of the license or certificate which the motor carrier accepted as equivalent to the driver's road test pursuant to § 391.33, or the original of the written statement providing that the motor carrier determined the driver is not required by § 391.44(d) to complete a road test pursuant to § 391.44(d)(3)(ii)(A) and the original, or a copy, of the driver's certification required by § 391.44(d)(3)(i);
(b) Until March 22, 2022, the provisions of § 391.41(b)(10) do not apply to a driver who was a participant in good standing on March 31, 1996, in a waiver study program concerning the operation of commercial motor vehicles by drivers with visual impairment in one eye;
(4) On March 22, 2022, the provisions of paragraph (b) of this section are no longer in effect, and any medical examiner's certificate issued under § 391.43 on the basis that the driver is qualified by operation of the provisions of paragraph (b) of this section, related to drivers with visual impairment in one eye, is void.
Issued under the authority of delegation in 49 CFR 1.87.